[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GJL":3},{"classification":4,"mappedDevices":43,"similarCandidates":44,"relatedClassifications":112,"syncDates":477,"translation":484,"marketSummary":490,"recalls":503,"k510s":505,"pmas":512},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":15,"raw":16,"created_at":38,"updated_at":39,"recall_count":40,"latest_recall_date":41,"k510_count":42,"pma_count":40,"event_count":40},1895,"GJL","Romanowsky Stains","1","864.1850","HE","Hematology","4","",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":35,"product_code":6,"review_panel":10,"gmp_exempt_flag":36,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":35,"medical_specialty_description":11,"summary_malfunction_reporting":37},{"k_number":18,"fei_number":20,"registration_number":33},[19],"K880544",[21,22,23,24,25,26,27,28,29,30,31,32],"2013736","3002805583","3044854712","3002809144","3016438761","3040937533","3009000266","1000122268","3033524192","3005333358","3011558129","3017970519",[21,22,23,24,25,26,27,34,29,30,31,32],"2247035","N","Y","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-24T02:00:47.808424+00:00",0,null,1,[],[45,53,61,68,76,83,88,95,101,107],{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":40,"vector_similarity":51,"score":52},3588,"自動染色装置","Ⅰ","70191000",0.157895,0.553914,0.0325225,{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":40,"vector_similarity":59,"score":60},2722,"歯科セラミックス用着色材料","Ⅱ","70823000",0.108696,0.571212,0.0308862,{"medical_device_id":62,"generic_name":63,"class_classification":56,"jmdn_code":64,"name_similarity":65,"definition_similarity":40,"vector_similarity":66,"score":67},1764,"硬性口腔鏡","70155000",0.121212,0.482998,0.0262626,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":40,"vector_similarity":74,"score":75},489,"ステンレス製縫合糸","Ⅲ","35383000",0.151515,0.446071,0.016129,{"medical_device_id":77,"generic_name":78,"class_classification":56,"jmdn_code":79,"name_similarity":80,"definition_similarity":40,"vector_similarity":81,"score":82},2680,"歯科用ステンレス鋼線","70792000",0.128205,0.410679,0.015873,{"medical_device_id":84,"generic_name":85,"class_classification":56,"jmdn_code":86,"name_similarity":40,"definition_similarity":40,"vector_similarity":87,"score":82},3003,"超音波診断用プローブ用洗浄消毒器","45058002",0.548249,{"medical_device_id":89,"generic_name":90,"class_classification":48,"jmdn_code":91,"name_similarity":92,"definition_similarity":40,"vector_similarity":93,"score":94},3374,"回転式肺活量計","70083000",0.125,0.407426,0.015625,{"medical_device_id":96,"generic_name":97,"class_classification":48,"jmdn_code":98,"name_similarity":99,"definition_similarity":40,"vector_similarity":100,"score":94},3407,"アノマロスコープ","16342000",0.0689655,0.538958,{"medical_device_id":102,"generic_name":103,"class_classification":56,"jmdn_code":104,"name_similarity":92,"definition_similarity":40,"vector_similarity":105,"score":106},2681,"歯科用ステンレス合金","70793000",0.384793,0.0153846,{"medical_device_id":108,"generic_name":109,"class_classification":48,"jmdn_code":110,"name_similarity":40,"definition_similarity":40,"vector_similarity":111,"score":106},4388,"色覚検査機器","12810000",0.526003,[113,117,121,125,129,133,137,141,145,148,152,156,159,163,166,169,172,176,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228,231,234,237,240,243,246,249,252,255,258,261,264,267,270,273,276,279,282,285,288,291,294,297,300,303,306,309,312,315,318,321,324,327,330,333,336,339,342,345,348,351,354,357,360,363,366,369,372,375,378,381,384,387,390,393,396,399,402,405,408,411,414,417,420,423,426,429,432,435,438,441,444,447,450,453,456,459,462,465,468,471,474],{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"JTS","Stains, Microbiologic",40,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"IAF","Wright'S Stain",33,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"LED","Stains, Chemical Solution",16,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"HZJ","Stain, Papanicolau",15,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"HYJ","Hematoxylin",14,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"HYB","Eosin Y",10,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"KQC","Stains, Hematology",9,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"HYK","Hematoxylin Harris'S",7,{"product_code":146,"device_name":147,"device_class":8,"k510_count":144},"KFC","Methylene Blue, Tissue Stain",{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"HYI","Iodine, Grams",6,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"HZT","Reagent, Schiff",5,{"product_code":157,"device_name":158,"device_class":8,"k510_count":155},"ICF","Crystal Violet For Histology",{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"HYF","Giemsa Stain",4,{"product_code":164,"device_name":165,"device_class":8,"k510_count":162},"HZH","Orange G",{"product_code":167,"device_name":168,"device_class":8,"k510_count":162},"ICL","Carbol Fuchsin",{"product_code":170,"device_name":171,"device_class":8,"k510_count":162},"IDC","Acridine Orange",{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"KJR","Erythrosin B",3,{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"HYW","Stain, Trichrome, Mallory'S",2,{"product_code":181,"device_name":182,"device_class":8,"k510_count":179},"HZA","Methyl Green",{"product_code":184,"device_name":185,"device_class":8,"k510_count":179},"HZC","Mucicarmine",{"product_code":187,"device_name":188,"device_class":8,"k510_count":179},"HZZ","Sudan Black B",{"product_code":190,"device_name":191,"device_class":8,"k510_count":179},"ICN","Biebrich Scarlet",{"product_code":193,"device_name":194,"device_class":8,"k510_count":179},"IDA","Alcian Blue",{"product_code":196,"device_name":197,"device_class":8,"k510_count":179},"KJK","Auramine O",{"product_code":199,"device_name":200,"device_class":8,"k510_count":42},"GGH","Iron Stains",{"product_code":202,"device_name":203,"device_class":8,"k510_count":42},"GJH","Stain, Reticulocyte",{"product_code":205,"device_name":206,"device_class":8,"k510_count":42},"HYC","Fast Green",{"product_code":208,"device_name":209,"device_class":8,"k510_count":42},"HYD","Fast Red Salt B",{"product_code":211,"device_name":212,"device_class":8,"k510_count":42},"HYG","Glenner'S Stain",{"product_code":214,"device_name":215,"device_class":8,"k510_count":42},"HYO","Hematoxylin Weigert'S",{"product_code":217,"device_name":218,"device_class":8,"k510_count":42},"HYS","Light Green",{"product_code":220,"device_name":221,"device_class":8,"k510_count":42},"HZG","Oil Red O",{"product_code":223,"device_name":224,"device_class":8,"k510_count":42},"HZL","Phloxine B",{"product_code":226,"device_name":227,"device_class":8,"k510_count":42},"HZO","Stain, Ponceau",{"product_code":229,"device_name":230,"device_class":8,"k510_count":42},"HZS","Safranin",{"product_code":232,"device_name":233,"device_class":8,"k510_count":42},"IAB","Toluidine Blue",{"product_code":235,"device_name":236,"device_class":8,"k510_count":42},"IAC","Van Gieson'S Stain",{"product_code":238,"device_name":239,"device_class":8,"k510_count":42},"IAE","Hematoxylin, Iron, Weigert'S",{"product_code":241,"device_name":242,"device_class":8,"k510_count":42},"ICC","Eosin B",{"product_code":244,"device_name":245,"device_class":8,"k510_count":42},"ICH","Congo Red",{"product_code":247,"device_name":248,"device_class":8,"k510_count":42},"ICJ","Carbol Night Blue",{"product_code":250,"device_name":251,"device_class":8,"k510_count":42},"ICX","Aniline",{"product_code":253,"device_name":254,"device_class":8,"k510_count":42},"IDF","Acid, Fuchsin",{"product_code":256,"device_name":257,"device_class":8,"k510_count":42},"KFD","Aniline Blue",{"product_code":259,"device_name":260,"device_class":8,"k510_count":42},"KFE","Neutral Red",{"product_code":262,"device_name":263,"device_class":8,"k510_count":42},"KJN","Brilliant Cresyl Blue",{"product_code":265,"device_name":266,"device_class":8,"k510_count":42},"KJX","Jenner Stain",{"product_code":268,"device_name":269,"device_class":8,"k510_count":42},"KJY","Malachite Green",{"product_code":271,"device_name":272,"device_class":8,"k510_count":42},"KKJ","Sudan Iii",{"product_code":274,"device_name":275,"device_class":8,"k510_count":42},"KKK","Sudan Iv",{"product_code":277,"device_name":278,"device_class":8,"k510_count":42},"LEE","Stains, Dye Solution",{"product_code":280,"device_name":281,"device_class":8,"k510_count":42},"LEF","Stains, Dye Powder",{"product_code":283,"device_name":284,"device_class":8,"k510_count":42},"LGY","Trypan Blue",{"product_code":286,"device_name":287,"device_class":8,"k510_count":40},"GHZ","Solution, Gugol Blue",{"product_code":289,"device_name":290,"device_class":8,"k510_count":40},"GJJ","Stains, Heinz Body",{"product_code":292,"device_name":293,"device_class":8,"k510_count":40},"HYE","Solution, Fontanna Silver",{"product_code":295,"device_name":296,"device_class":8,"k510_count":40},"HYH","Gold Chloride",{"product_code":298,"device_name":299,"device_class":8,"k510_count":40},"HYL","Hematoxylin Mayer'S",{"product_code":301,"device_name":302,"device_class":8,"k510_count":40},"HYQ","Iron Chloride-Weigert",{"product_code":304,"device_name":305,"device_class":8,"k510_count":40},"HYR","Leuco-Patent Blue",{"product_code":307,"device_name":308,"device_class":8,"k510_count":40},"HYT","Luxol Fast Blue",{"product_code":310,"device_name":311,"device_class":8,"k510_count":40},"HYY","Metanil Yellow",{"product_code":313,"device_name":314,"device_class":8,"k510_count":40},"HYZ","Methenamine Silver",{"product_code":316,"device_name":317,"device_class":8,"k510_count":40},"HZD","Muller'S Colloidal Iron",{"product_code":319,"device_name":320,"device_class":8,"k510_count":40},"HZE","Nile Blue",{"product_code":322,"device_name":323,"device_class":8,"k510_count":40},"HZF","Nuclear Fast Red",{"product_code":325,"device_name":326,"device_class":8,"k510_count":40},"HZM","Hematoxylin, Acid, Phosphotungstic",{"product_code":328,"device_name":329,"device_class":8,"k510_count":40},"HZN","Picro Methyl Blue",{"product_code":331,"device_name":332,"device_class":8,"k510_count":40},"HZP","Pyronin",{"product_code":334,"device_name":335,"device_class":8,"k510_count":40},"HZQ","Red-Violet Lb",{"product_code":337,"device_name":338,"device_class":8,"k510_count":40},"HZR","Resorcin Fuchsin",{"product_code":340,"device_name":341,"device_class":8,"k510_count":40},"HZX","Silver Nitrate",{"product_code":343,"device_name":344,"device_class":8,"k510_count":40},"HZY","Sirius Red",{"product_code":346,"device_name":347,"device_class":8,"k510_count":40},"IAA","Titan Yellow",{"product_code":349,"device_name":350,"device_class":8,"k510_count":40},"IAD","Van Gieson'S Picro-Fuchsin",{"product_code":352,"device_name":353,"device_class":8,"k510_count":40},"ICD","Darrow Red",{"product_code":355,"device_name":356,"device_class":8,"k510_count":40},"ICG","Cresyl Violet Acetate",{"product_code":358,"device_name":359,"device_class":8,"k510_count":40},"ICI","Hematoxylin, Chrome Alum",{"product_code":361,"device_name":362,"device_class":8,"k510_count":40},"ICM","Brilliant Yellow",{"product_code":364,"device_name":365,"device_class":8,"k510_count":40},"ICO","Best'S Carmine",{"product_code":367,"device_name":368,"device_class":8,"k510_count":40},"ICQ","Azure A",{"product_code":370,"device_name":371,"device_class":8,"k510_count":40},"ICR","Azocarmine B",{"product_code":373,"device_name":374,"device_class":8,"k510_count":40},"ICS","Azocarmine G",{"product_code":376,"device_name":377,"device_class":8,"k510_count":40},"ICT","Azan Counterstain",{"product_code":379,"device_name":380,"device_class":8,"k510_count":40},"ICY","Acid, Aniline, Fuchsin",{"product_code":382,"device_name":383,"device_class":8,"k510_count":40},"ICZ","Ammoniacal Silver Hydroxide Silver Nitrate",{"product_code":385,"device_name":386,"device_class":8,"k510_count":40},"IDB","Aldehyde Fuchsin",{"product_code":388,"device_name":389,"device_class":8,"k510_count":40},"IDD","Alizarin Red",{"product_code":391,"device_name":392,"device_class":8,"k510_count":40},"IDE","Acid, Hematein",{"product_code":394,"device_name":395,"device_class":8,"k510_count":40},"JCH","Esterase",{"product_code":397,"device_name":398,"device_class":8,"k510_count":40},"JCI","Acid Phosphatase, Cytochemical",{"product_code":400,"device_name":401,"device_class":8,"k510_count":40},"KJL","Azure C",{"product_code":403,"device_name":404,"device_class":8,"k510_count":40},"KJM","Bismarck Brown Y",{"product_code":406,"device_name":407,"device_class":8,"k510_count":40},"KJO","Brilliant Green",{"product_code":409,"device_name":410,"device_class":8,"k510_count":40},"KJP","Carmine",{"product_code":412,"device_name":413,"device_class":8,"k510_count":40},"KJQ","Chlorazol Black E",{"product_code":415,"device_name":416,"device_class":8,"k510_count":40},"KJS","Ethyl Eosin",{"product_code":418,"device_name":419,"device_class":8,"k510_count":40},"KJT","Indigocarmine",{"product_code":421,"device_name":422,"device_class":8,"k510_count":40},"KJW","Janus Green B",{"product_code":424,"device_name":425,"device_class":8,"k510_count":40},"KJZ","Martius Yellow",{"product_code":427,"device_name":428,"device_class":8,"k510_count":40},"KKA","Methyl Orange",{"product_code":430,"device_name":431,"device_class":8,"k510_count":40},"KKB","Methyl Violet 2b",{"product_code":433,"device_name":434,"device_class":8,"k510_count":40},"KKC","Methylene Violet",{"product_code":436,"device_name":437,"device_class":8,"k510_count":40},"KKD","Nigrosin",{"product_code":439,"device_name":440,"device_class":8,"k510_count":40},"KKE","Orange Ii",{"product_code":442,"device_name":443,"device_class":8,"k510_count":40},"KKF","Orcein",{"product_code":445,"device_name":446,"device_class":8,"k510_count":40},"KKG","Protargol S",{"product_code":448,"device_name":449,"device_class":8,"k510_count":40},"KKH","Tablet, Resazurin",{"product_code":451,"device_name":452,"device_class":8,"k510_count":40},"KKI","Rose Bengal",{"product_code":454,"device_name":455,"device_class":8,"k510_count":40},"KKL","Thionin",{"product_code":457,"device_name":458,"device_class":8,"k510_count":40},"KKM","Methylene Blue Thiocyanate",{"product_code":460,"device_name":461,"device_class":8,"k510_count":40},"KKP","Solution, Silver Carbonate",{"product_code":463,"device_name":464,"device_class":8,"k510_count":40},"KKQ","Sodium Periodate",{"product_code":466,"device_name":467,"device_class":8,"k510_count":40},"KKR","Potassium Periodate",{"product_code":469,"device_name":470,"device_class":8,"k510_count":40},"KKS","Acid, Periodic",{"product_code":472,"device_name":473,"device_class":8,"k510_count":40},"KKT","Hematoxylin, Ehrlich'S",{"product_code":475,"device_name":476,"device_class":8,"k510_count":40},"KKW","Basic Fuchsin",{"510k":478,"classification":479,"enforcement":480,"event":481,"pma":482,"warning_letter":483},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":485,"definition_ja":41,"commentary_ja":486,"model_name":487,"source_hash":488,"reviewed_by":41,"reviewed_at":41,"created_at":489,"updated_at":489},"ロマノフスキー染色液","本品は血液細胞の形態観察のために用いられる染色試薬です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされています。これはリスクが低く、既存の性能基準等により安全性・有効性が十分に担保されると考えられる機器に適用される規制上の取り扱いです。","claude-sonnet-5","26fb2a25c55f5122df0f0132fbc860fac74f23ce056001bf4e23ff52b793d18f","2026-08-24T01:53:33.449047+00:00",{"product_code":6,"summary_ja":491,"stats":492,"stats_hash":501,"model_name":487,"created_at":502,"updated_at":502},"本製品は届出免除区分であり、510(k)は累計1件、参入企業数は1社にとどまり、直近5年間の届出実績は確認されていません。不具合報告および回収については、いずれも累計件数が0件であり、報告・実績は確認されていません。",{"pma":493,"k510":494,"as_of":496,"events":497,"recalls":498,"top_problems":500},{"latest":41,"originals":40,"supplements":40},{"total":42,"last5y":40,"latest":495,"applicants":42},"1988-04-01","2026-08",{"death":40,"other":40,"total":40,"injury":40,"last5y":40,"malfunction":40,"latest_month":41},{"total":40,"last5y":40,"latest":41,"class_i":40,"class_ii":40,"class_iii":40,"top_root_causes":499},[],[],"4e378ba00a5d986380dba326f1c57a86a41f547d71624c809107077ee9c5d6fe","2026-08-24T04:26:51.412735+00:00",{"items":504,"total":40},[],{"items":506,"total":42},[507],{"k_number":19,"device_name":508,"applicant":509,"decision_date":495,"clearance_type":510,"decision_code":511,"statement_or_summary":41},"WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY","Wescor, Inc.","Traditional","SESE",{"items":513,"total":40},[]]