[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KKJ":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":106,"syncDates":471,"translation":478,"marketSummary":484,"recalls":497,"k510s":499,"pmas":506},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":16,"raw":17,"created_at":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":35,"event_count":35},3002,"KKJ","Sudan Iii","1","864.1850","HE","Hematology","PA","4","",false,true,{"openfda":18,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":30,"product_code":6,"review_panel":12,"gmp_exempt_flag":31,"third_party_flag":30,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":30,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"k_number":19,"fei_number":21,"registration_number":28},[20],"K810875",[22,23,24,25,26,27],"3003103936","2013736","3006365273","2025606","1625587","3008174888",[23,29,24,25,26,27],"1125908","N","Y","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-24T02:00:47.808424+00:00",0,null,1,[],[40,48,56,61,68,75,82,88,94,99],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":35,"vector_similarity":46,"score":47},535,"単回使用クラスⅢ処置キット","Ⅲ","33961003",0.12766,0.505264,0.0327869,{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":35,"vector_similarity":54,"score":55},2265,"単回使用クラスⅡ処置キット","Ⅱ","33961002",0.106383,0.373214,0.016129,{"medical_device_id":57,"generic_name":58,"class_classification":51,"jmdn_code":59,"name_similarity":35,"definition_similarity":35,"vector_similarity":60,"score":55},3183,"歯科三次元積層造形用金属材料","71060002",0.474478,{"medical_device_id":62,"generic_name":63,"class_classification":51,"jmdn_code":64,"name_similarity":65,"definition_similarity":35,"vector_similarity":66,"score":67},2057,"サンプドレーン","15270000",0.105263,0.359493,0.015873,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":35,"vector_similarity":74,"score":67},3801,"腱膜瘤防護具","Ⅰ","13565000",0.0434783,0.473587,{"medical_device_id":76,"generic_name":77,"class_classification":43,"jmdn_code":78,"name_similarity":79,"definition_similarity":35,"vector_similarity":80,"score":81},1121,"ヘパリン使用眼内ドレーン","61127003",0.0232558,0.466503,0.015625,{"medical_device_id":83,"generic_name":84,"class_classification":71,"jmdn_code":85,"name_similarity":86,"definition_similarity":35,"vector_similarity":87,"score":81},4190,"手術用のこぎり","13448001",0.1,0.379818,{"medical_device_id":89,"generic_name":90,"class_classification":51,"jmdn_code":91,"name_similarity":35,"definition_similarity":35,"vector_similarity":92,"score":93},1727,"硬性ウレスロトーム","17633000",0.461835,0.0153846,{"medical_device_id":95,"generic_name":96,"class_classification":51,"jmdn_code":97,"name_similarity":86,"definition_similarity":35,"vector_similarity":98,"score":93},1938,"吸引キット","13846000",0.41921,{"medical_device_id":100,"generic_name":101,"class_classification":102,"jmdn_code":103,"name_similarity":86,"definition_similarity":35,"vector_similarity":104,"score":105},224,"腸骨動脈用ステント","Ⅳ","44279000",0.380433,0.0151515,[107,111,115,119,123,127,131,135,139,142,146,150,153,157,160,163,166,170,174,177,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228,231,234,237,240,243,246,249,252,255,258,261,264,267,270,273,276,279,282,285,288,291,294,297,300,303,306,309,312,315,318,321,324,327,330,333,336,339,342,345,348,351,354,357,360,363,366,369,372,375,378,381,384,387,390,393,396,399,402,405,408,411,414,417,420,423,426,429,432,435,438,441,444,447,450,453,456,459,462,465,468],{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"JTS","Stains, Microbiologic",40,{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"IAF","Wright'S Stain",33,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"LED","Stains, Chemical Solution",16,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"HZJ","Stain, Papanicolau",15,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"HYJ","Hematoxylin",14,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"HYB","Eosin Y",10,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"KQC","Stains, Hematology",9,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"HYK","Hematoxylin Harris'S",7,{"product_code":140,"device_name":141,"device_class":8,"k510_count":138},"KFC","Methylene Blue, Tissue Stain",{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"HYI","Iodine, Grams",6,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"HZT","Reagent, Schiff",5,{"product_code":151,"device_name":152,"device_class":8,"k510_count":149},"ICF","Crystal Violet For Histology",{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"HYF","Giemsa Stain",4,{"product_code":158,"device_name":159,"device_class":8,"k510_count":156},"HZH","Orange G",{"product_code":161,"device_name":162,"device_class":8,"k510_count":156},"ICL","Carbol Fuchsin",{"product_code":164,"device_name":165,"device_class":8,"k510_count":156},"IDC","Acridine Orange",{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"KJR","Erythrosin B",3,{"product_code":171,"device_name":172,"device_class":8,"k510_count":173},"HYW","Stain, Trichrome, Mallory'S",2,{"product_code":175,"device_name":176,"device_class":8,"k510_count":173},"HZA","Methyl Green",{"product_code":178,"device_name":179,"device_class":8,"k510_count":173},"HZC","Mucicarmine",{"product_code":181,"device_name":182,"device_class":8,"k510_count":173},"HZZ","Sudan Black B",{"product_code":184,"device_name":185,"device_class":8,"k510_count":173},"ICN","Biebrich Scarlet",{"product_code":187,"device_name":188,"device_class":8,"k510_count":173},"IDA","Alcian Blue",{"product_code":190,"device_name":191,"device_class":8,"k510_count":173},"KJK","Auramine O",{"product_code":193,"device_name":194,"device_class":8,"k510_count":37},"GGH","Iron Stains",{"product_code":196,"device_name":197,"device_class":8,"k510_count":37},"GJH","Stain, Reticulocyte",{"product_code":199,"device_name":200,"device_class":8,"k510_count":37},"GJL","Romanowsky Stains",{"product_code":202,"device_name":203,"device_class":8,"k510_count":37},"HYC","Fast Green",{"product_code":205,"device_name":206,"device_class":8,"k510_count":37},"HYD","Fast Red Salt B",{"product_code":208,"device_name":209,"device_class":8,"k510_count":37},"HYG","Glenner'S Stain",{"product_code":211,"device_name":212,"device_class":8,"k510_count":37},"HYO","Hematoxylin Weigert'S",{"product_code":214,"device_name":215,"device_class":8,"k510_count":37},"HYS","Light Green",{"product_code":217,"device_name":218,"device_class":8,"k510_count":37},"HZG","Oil Red O",{"product_code":220,"device_name":221,"device_class":8,"k510_count":37},"HZL","Phloxine B",{"product_code":223,"device_name":224,"device_class":8,"k510_count":37},"HZO","Stain, Ponceau",{"product_code":226,"device_name":227,"device_class":8,"k510_count":37},"HZS","Safranin",{"product_code":229,"device_name":230,"device_class":8,"k510_count":37},"IAB","Toluidine Blue",{"product_code":232,"device_name":233,"device_class":8,"k510_count":37},"IAC","Van Gieson'S Stain",{"product_code":235,"device_name":236,"device_class":8,"k510_count":37},"IAE","Hematoxylin, Iron, Weigert'S",{"product_code":238,"device_name":239,"device_class":8,"k510_count":37},"ICC","Eosin B",{"product_code":241,"device_name":242,"device_class":8,"k510_count":37},"ICH","Congo Red",{"product_code":244,"device_name":245,"device_class":8,"k510_count":37},"ICJ","Carbol Night Blue",{"product_code":247,"device_name":248,"device_class":8,"k510_count":37},"ICX","Aniline",{"product_code":250,"device_name":251,"device_class":8,"k510_count":37},"IDF","Acid, Fuchsin",{"product_code":253,"device_name":254,"device_class":8,"k510_count":37},"KFD","Aniline Blue",{"product_code":256,"device_name":257,"device_class":8,"k510_count":37},"KFE","Neutral Red",{"product_code":259,"device_name":260,"device_class":8,"k510_count":37},"KJN","Brilliant Cresyl Blue",{"product_code":262,"device_name":263,"device_class":8,"k510_count":37},"KJX","Jenner Stain",{"product_code":265,"device_name":266,"device_class":8,"k510_count":37},"KJY","Malachite Green",{"product_code":268,"device_name":269,"device_class":8,"k510_count":37},"KKK","Sudan Iv",{"product_code":271,"device_name":272,"device_class":8,"k510_count":37},"LEE","Stains, Dye Solution",{"product_code":274,"device_name":275,"device_class":8,"k510_count":37},"LEF","Stains, Dye Powder",{"product_code":277,"device_name":278,"device_class":8,"k510_count":37},"LGY","Trypan Blue",{"product_code":280,"device_name":281,"device_class":8,"k510_count":35},"GHZ","Solution, Gugol Blue",{"product_code":283,"device_name":284,"device_class":8,"k510_count":35},"GJJ","Stains, Heinz Body",{"product_code":286,"device_name":287,"device_class":8,"k510_count":35},"HYE","Solution, Fontanna Silver",{"product_code":289,"device_name":290,"device_class":8,"k510_count":35},"HYH","Gold Chloride",{"product_code":292,"device_name":293,"device_class":8,"k510_count":35},"HYL","Hematoxylin Mayer'S",{"product_code":295,"device_name":296,"device_class":8,"k510_count":35},"HYQ","Iron Chloride-Weigert",{"product_code":298,"device_name":299,"device_class":8,"k510_count":35},"HYR","Leuco-Patent Blue",{"product_code":301,"device_name":302,"device_class":8,"k510_count":35},"HYT","Luxol Fast Blue",{"product_code":304,"device_name":305,"device_class":8,"k510_count":35},"HYY","Metanil Yellow",{"product_code":307,"device_name":308,"device_class":8,"k510_count":35},"HYZ","Methenamine Silver",{"product_code":310,"device_name":311,"device_class":8,"k510_count":35},"HZD","Muller'S Colloidal Iron",{"product_code":313,"device_name":314,"device_class":8,"k510_count":35},"HZE","Nile Blue",{"product_code":316,"device_name":317,"device_class":8,"k510_count":35},"HZF","Nuclear Fast Red",{"product_code":319,"device_name":320,"device_class":8,"k510_count":35},"HZM","Hematoxylin, Acid, Phosphotungstic",{"product_code":322,"device_name":323,"device_class":8,"k510_count":35},"HZN","Picro Methyl Blue",{"product_code":325,"device_name":326,"device_class":8,"k510_count":35},"HZP","Pyronin",{"product_code":328,"device_name":329,"device_class":8,"k510_count":35},"HZQ","Red-Violet Lb",{"product_code":331,"device_name":332,"device_class":8,"k510_count":35},"HZR","Resorcin Fuchsin",{"product_code":334,"device_name":335,"device_class":8,"k510_count":35},"HZX","Silver Nitrate",{"product_code":337,"device_name":338,"device_class":8,"k510_count":35},"HZY","Sirius Red",{"product_code":340,"device_name":341,"device_class":8,"k510_count":35},"IAA","Titan Yellow",{"product_code":343,"device_name":344,"device_class":8,"k510_count":35},"IAD","Van Gieson'S Picro-Fuchsin",{"product_code":346,"device_name":347,"device_class":8,"k510_count":35},"ICD","Darrow Red",{"product_code":349,"device_name":350,"device_class":8,"k510_count":35},"ICG","Cresyl Violet Acetate",{"product_code":352,"device_name":353,"device_class":8,"k510_count":35},"ICI","Hematoxylin, Chrome Alum",{"product_code":355,"device_name":356,"device_class":8,"k510_count":35},"ICM","Brilliant Yellow",{"product_code":358,"device_name":359,"device_class":8,"k510_count":35},"ICO","Best'S Carmine",{"product_code":361,"device_name":362,"device_class":8,"k510_count":35},"ICQ","Azure A",{"product_code":364,"device_name":365,"device_class":8,"k510_count":35},"ICR","Azocarmine B",{"product_code":367,"device_name":368,"device_class":8,"k510_count":35},"ICS","Azocarmine G",{"product_code":370,"device_name":371,"device_class":8,"k510_count":35},"ICT","Azan Counterstain",{"product_code":373,"device_name":374,"device_class":8,"k510_count":35},"ICY","Acid, Aniline, Fuchsin",{"product_code":376,"device_name":377,"device_class":8,"k510_count":35},"ICZ","Ammoniacal Silver Hydroxide Silver Nitrate",{"product_code":379,"device_name":380,"device_class":8,"k510_count":35},"IDB","Aldehyde Fuchsin",{"product_code":382,"device_name":383,"device_class":8,"k510_count":35},"IDD","Alizarin Red",{"product_code":385,"device_name":386,"device_class":8,"k510_count":35},"IDE","Acid, Hematein",{"product_code":388,"device_name":389,"device_class":8,"k510_count":35},"JCH","Esterase",{"product_code":391,"device_name":392,"device_class":8,"k510_count":35},"JCI","Acid Phosphatase, Cytochemical",{"product_code":394,"device_name":395,"device_class":8,"k510_count":35},"KJL","Azure C",{"product_code":397,"device_name":398,"device_class":8,"k510_count":35},"KJM","Bismarck Brown Y",{"product_code":400,"device_name":401,"device_class":8,"k510_count":35},"KJO","Brilliant Green",{"product_code":403,"device_name":404,"device_class":8,"k510_count":35},"KJP","Carmine",{"product_code":406,"device_name":407,"device_class":8,"k510_count":35},"KJQ","Chlorazol Black E",{"product_code":409,"device_name":410,"device_class":8,"k510_count":35},"KJS","Ethyl Eosin",{"product_code":412,"device_name":413,"device_class":8,"k510_count":35},"KJT","Indigocarmine",{"product_code":415,"device_name":416,"device_class":8,"k510_count":35},"KJW","Janus Green B",{"product_code":418,"device_name":419,"device_class":8,"k510_count":35},"KJZ","Martius Yellow",{"product_code":421,"device_name":422,"device_class":8,"k510_count":35},"KKA","Methyl Orange",{"product_code":424,"device_name":425,"device_class":8,"k510_count":35},"KKB","Methyl Violet 2b",{"product_code":427,"device_name":428,"device_class":8,"k510_count":35},"KKC","Methylene Violet",{"product_code":430,"device_name":431,"device_class":8,"k510_count":35},"KKD","Nigrosin",{"product_code":433,"device_name":434,"device_class":8,"k510_count":35},"KKE","Orange Ii",{"product_code":436,"device_name":437,"device_class":8,"k510_count":35},"KKF","Orcein",{"product_code":439,"device_name":440,"device_class":8,"k510_count":35},"KKG","Protargol S",{"product_code":442,"device_name":443,"device_class":8,"k510_count":35},"KKH","Tablet, Resazurin",{"product_code":445,"device_name":446,"device_class":8,"k510_count":35},"KKI","Rose Bengal",{"product_code":448,"device_name":449,"device_class":8,"k510_count":35},"KKL","Thionin",{"product_code":451,"device_name":452,"device_class":8,"k510_count":35},"KKM","Methylene Blue Thiocyanate",{"product_code":454,"device_name":455,"device_class":8,"k510_count":35},"KKP","Solution, Silver Carbonate",{"product_code":457,"device_name":458,"device_class":8,"k510_count":35},"KKQ","Sodium Periodate",{"product_code":460,"device_name":461,"device_class":8,"k510_count":35},"KKR","Potassium Periodate",{"product_code":463,"device_name":464,"device_class":8,"k510_count":35},"KKS","Acid, Periodic",{"product_code":466,"device_name":467,"device_class":8,"k510_count":35},"KKT","Hematoxylin, Ehrlich'S",{"product_code":469,"device_name":470,"device_class":8,"k510_count":35},"KKW","Basic Fuchsin",{"510k":472,"classification":473,"enforcement":474,"event":475,"pma":476,"warning_letter":477},"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":479,"definition_ja":36,"commentary_ja":480,"model_name":481,"source_hash":482,"reviewed_by":36,"reviewed_at":36,"created_at":483,"updated_at":483},"スダンIII染色液","本品は米国 FDA の分類上クラスIに位置づけられており、市販前届出（510(k)）が免除されている医療機器です。クラスIは一般的に人体へのリスクが低い機器に適用される区分であり、市販前届出（510(k)）や市販前承認（PMA）による個別審査を経ることなく、一般的な規制（General Controls）の遵守のみで市場に流通させることが認められています。","claude-sonnet-5","1124cac5913b30d74b28fdc3dd7de76810b32886007718a7f50b647066b07b9b","2026-08-24T02:07:08.607632+00:00",{"product_code":6,"summary_ja":485,"stats":486,"stats_hash":495,"model_name":481,"created_at":496,"updated_at":496},"本製品はクラス I・届出免除の区分で、510(k)の累計件数は1件、参入企業数は1社にとどまり、直近5年の届出実績は確認されていません。不具合報告（MDR）の累計件数は0件で、報告は確認されていません。回収についても累計件数は0件であり、該当する記録は確認されていません。",{"pma":487,"k510":488,"as_of":490,"events":491,"recalls":492,"top_problems":494},{"latest":36,"originals":35,"supplements":35},{"total":37,"last5y":35,"latest":489,"applicants":37},"1981-05-01","2026-08",{"death":35,"other":35,"total":35,"injury":35,"last5y":35,"malfunction":35,"latest_month":36},{"total":35,"last5y":35,"latest":36,"class_i":35,"class_ii":35,"class_iii":35,"top_root_causes":493},[],[],"d23f921a112c360f13a700e802f8faaf0995a58f46d2d47b62727ae1bca3ec79","2026-08-24T04:44:46.948226+00:00",{"items":498,"total":35},[],{"items":500,"total":37},[501],{"k_number":20,"device_name":502,"applicant":503,"decision_date":489,"clearance_type":504,"decision_code":505,"statement_or_summary":36},"FECAL STAINING KIT","Jayco Pharmaceuticals","Traditional","SESE",{"items":507,"total":35},[]]