[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KFE":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":102,"syncDates":467,"translation":474,"marketSummary":480,"recalls":493,"k510s":495,"pmas":502},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":33},2588,"KFE","Neutral Red","1","864.1850","HE","Hematology","PA","4","",false,true,{"openfda":18,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":12,"gmp_exempt_flag":29,"third_party_flag":28,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":19,"fei_number":21,"registration_number":26},[20],"K871477",[22,23,24,25],"3002806906","1937990","1000138378","1045125",[27,23,24,25],"9610140","N","Y","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:47.318533+00:00",0,null,1,[],[38,46,51,58,63,71,76,84,90,97],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":33,"vector_similarity":44,"score":45},3952,"電動式中性子治療台","Ⅰ","40691000",0.205882,0.421831,0.0163934,{"medical_device_id":47,"generic_name":48,"class_classification":41,"jmdn_code":49,"name_similarity":33,"definition_similarity":33,"vector_similarity":50,"score":45},4390,"色覚検査表","35898000",0.549133,{"medical_device_id":52,"generic_name":53,"class_classification":41,"jmdn_code":54,"name_similarity":55,"definition_similarity":33,"vector_similarity":56,"score":57},3951,"非電動式中性子治療台","40690000",0.194444,0.423198,0.016129,{"medical_device_id":59,"generic_name":60,"class_classification":41,"jmdn_code":61,"name_similarity":33,"definition_similarity":33,"vector_similarity":62,"score":57},4389,"色覚検査用具","32687000",0.548503,{"medical_device_id":64,"generic_name":65,"class_classification":66,"jmdn_code":67,"name_similarity":68,"definition_similarity":33,"vector_similarity":69,"score":70},182,"中枢神経用カフ","Ⅳ","33385004",0.185185,0.415343,0.015873,{"medical_device_id":72,"generic_name":73,"class_classification":41,"jmdn_code":74,"name_similarity":33,"definition_similarity":33,"vector_similarity":75,"score":70},4391,"簡易色覚検査用具","37066000",0.5396,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":33,"vector_similarity":82,"score":83},2752,"歯科用色調適合確認材料","Ⅱ","70845000",0.0217391,0.538207,0.015625,{"medical_device_id":85,"generic_name":86,"class_classification":41,"jmdn_code":87,"name_similarity":88,"definition_similarity":33,"vector_similarity":89,"score":83},3595,"再使用可能な動脈用注射針","12747001",0.166667,0.415948,{"medical_device_id":91,"generic_name":92,"class_classification":41,"jmdn_code":93,"name_similarity":94,"definition_similarity":33,"vector_similarity":95,"score":96},4274,"歯科用開創器","13380000",0.16,0.407693,0.0153846,{"medical_device_id":98,"generic_name":99,"class_classification":41,"jmdn_code":100,"name_similarity":33,"definition_similarity":33,"vector_similarity":101,"score":96},4388,"色覚検査機器","12810000",0.534621,[103,107,111,115,119,123,127,131,135,138,142,146,149,153,156,159,162,166,170,173,176,179,182,185,188,191,194,197,200,203,206,209,212,215,218,221,224,227,230,233,236,239,242,245,248,251,254,257,260,263,266,269,272,275,278,281,284,287,290,293,296,299,302,305,308,311,314,317,320,323,326,329,332,335,338,341,344,347,350,353,356,359,362,365,368,371,374,377,380,383,386,389,392,395,398,401,404,407,410,413,416,419,422,425,428,431,434,437,440,443,446,449,452,455,458,461,464],{"product_code":104,"device_name":105,"device_class":8,"k510_count":106},"JTS","Stains, Microbiologic",40,{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"IAF","Wright'S Stain",33,{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"LED","Stains, Chemical Solution",16,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"HZJ","Stain, Papanicolau",15,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"HYJ","Hematoxylin",14,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"HYB","Eosin Y",10,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"KQC","Stains, Hematology",9,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"HYK","Hematoxylin Harris'S",7,{"product_code":136,"device_name":137,"device_class":8,"k510_count":134},"KFC","Methylene Blue, Tissue Stain",{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"HYI","Iodine, Grams",6,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"HZT","Reagent, Schiff",5,{"product_code":147,"device_name":148,"device_class":8,"k510_count":145},"ICF","Crystal Violet For Histology",{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"HYF","Giemsa Stain",4,{"product_code":154,"device_name":155,"device_class":8,"k510_count":152},"HZH","Orange G",{"product_code":157,"device_name":158,"device_class":8,"k510_count":152},"ICL","Carbol Fuchsin",{"product_code":160,"device_name":161,"device_class":8,"k510_count":152},"IDC","Acridine Orange",{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"KJR","Erythrosin B",3,{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"HYW","Stain, Trichrome, Mallory'S",2,{"product_code":171,"device_name":172,"device_class":8,"k510_count":169},"HZA","Methyl Green",{"product_code":174,"device_name":175,"device_class":8,"k510_count":169},"HZC","Mucicarmine",{"product_code":177,"device_name":178,"device_class":8,"k510_count":169},"HZZ","Sudan Black B",{"product_code":180,"device_name":181,"device_class":8,"k510_count":169},"ICN","Biebrich Scarlet",{"product_code":183,"device_name":184,"device_class":8,"k510_count":169},"IDA","Alcian Blue",{"product_code":186,"device_name":187,"device_class":8,"k510_count":169},"KJK","Auramine O",{"product_code":189,"device_name":190,"device_class":8,"k510_count":35},"GGH","Iron Stains",{"product_code":192,"device_name":193,"device_class":8,"k510_count":35},"GJH","Stain, Reticulocyte",{"product_code":195,"device_name":196,"device_class":8,"k510_count":35},"GJL","Romanowsky Stains",{"product_code":198,"device_name":199,"device_class":8,"k510_count":35},"HYC","Fast Green",{"product_code":201,"device_name":202,"device_class":8,"k510_count":35},"HYD","Fast Red Salt B",{"product_code":204,"device_name":205,"device_class":8,"k510_count":35},"HYG","Glenner'S Stain",{"product_code":207,"device_name":208,"device_class":8,"k510_count":35},"HYO","Hematoxylin Weigert'S",{"product_code":210,"device_name":211,"device_class":8,"k510_count":35},"HYS","Light Green",{"product_code":213,"device_name":214,"device_class":8,"k510_count":35},"HZG","Oil Red O",{"product_code":216,"device_name":217,"device_class":8,"k510_count":35},"HZL","Phloxine B",{"product_code":219,"device_name":220,"device_class":8,"k510_count":35},"HZO","Stain, Ponceau",{"product_code":222,"device_name":223,"device_class":8,"k510_count":35},"HZS","Safranin",{"product_code":225,"device_name":226,"device_class":8,"k510_count":35},"IAB","Toluidine Blue",{"product_code":228,"device_name":229,"device_class":8,"k510_count":35},"IAC","Van Gieson'S Stain",{"product_code":231,"device_name":232,"device_class":8,"k510_count":35},"IAE","Hematoxylin, Iron, Weigert'S",{"product_code":234,"device_name":235,"device_class":8,"k510_count":35},"ICC","Eosin B",{"product_code":237,"device_name":238,"device_class":8,"k510_count":35},"ICH","Congo Red",{"product_code":240,"device_name":241,"device_class":8,"k510_count":35},"ICJ","Carbol Night Blue",{"product_code":243,"device_name":244,"device_class":8,"k510_count":35},"ICX","Aniline",{"product_code":246,"device_name":247,"device_class":8,"k510_count":35},"IDF","Acid, Fuchsin",{"product_code":249,"device_name":250,"device_class":8,"k510_count":35},"KFD","Aniline Blue",{"product_code":252,"device_name":253,"device_class":8,"k510_count":35},"KJN","Brilliant Cresyl Blue",{"product_code":255,"device_name":256,"device_class":8,"k510_count":35},"KJX","Jenner Stain",{"product_code":258,"device_name":259,"device_class":8,"k510_count":35},"KJY","Malachite Green",{"product_code":261,"device_name":262,"device_class":8,"k510_count":35},"KKJ","Sudan Iii",{"product_code":264,"device_name":265,"device_class":8,"k510_count":35},"KKK","Sudan Iv",{"product_code":267,"device_name":268,"device_class":8,"k510_count":35},"LEE","Stains, Dye Solution",{"product_code":270,"device_name":271,"device_class":8,"k510_count":35},"LEF","Stains, Dye Powder",{"product_code":273,"device_name":274,"device_class":8,"k510_count":35},"LGY","Trypan Blue",{"product_code":276,"device_name":277,"device_class":8,"k510_count":33},"GHZ","Solution, Gugol Blue",{"product_code":279,"device_name":280,"device_class":8,"k510_count":33},"GJJ","Stains, Heinz Body",{"product_code":282,"device_name":283,"device_class":8,"k510_count":33},"HYE","Solution, Fontanna Silver",{"product_code":285,"device_name":286,"device_class":8,"k510_count":33},"HYH","Gold Chloride",{"product_code":288,"device_name":289,"device_class":8,"k510_count":33},"HYL","Hematoxylin Mayer'S",{"product_code":291,"device_name":292,"device_class":8,"k510_count":33},"HYQ","Iron Chloride-Weigert",{"product_code":294,"device_name":295,"device_class":8,"k510_count":33},"HYR","Leuco-Patent Blue",{"product_code":297,"device_name":298,"device_class":8,"k510_count":33},"HYT","Luxol Fast Blue",{"product_code":300,"device_name":301,"device_class":8,"k510_count":33},"HYY","Metanil Yellow",{"product_code":303,"device_name":304,"device_class":8,"k510_count":33},"HYZ","Methenamine Silver",{"product_code":306,"device_name":307,"device_class":8,"k510_count":33},"HZD","Muller'S Colloidal Iron",{"product_code":309,"device_name":310,"device_class":8,"k510_count":33},"HZE","Nile Blue",{"product_code":312,"device_name":313,"device_class":8,"k510_count":33},"HZF","Nuclear Fast Red",{"product_code":315,"device_name":316,"device_class":8,"k510_count":33},"HZM","Hematoxylin, Acid, Phosphotungstic",{"product_code":318,"device_name":319,"device_class":8,"k510_count":33},"HZN","Picro Methyl Blue",{"product_code":321,"device_name":322,"device_class":8,"k510_count":33},"HZP","Pyronin",{"product_code":324,"device_name":325,"device_class":8,"k510_count":33},"HZQ","Red-Violet Lb",{"product_code":327,"device_name":328,"device_class":8,"k510_count":33},"HZR","Resorcin Fuchsin",{"product_code":330,"device_name":331,"device_class":8,"k510_count":33},"HZX","Silver Nitrate",{"product_code":333,"device_name":334,"device_class":8,"k510_count":33},"HZY","Sirius Red",{"product_code":336,"device_name":337,"device_class":8,"k510_count":33},"IAA","Titan Yellow",{"product_code":339,"device_name":340,"device_class":8,"k510_count":33},"IAD","Van Gieson'S Picro-Fuchsin",{"product_code":342,"device_name":343,"device_class":8,"k510_count":33},"ICD","Darrow Red",{"product_code":345,"device_name":346,"device_class":8,"k510_count":33},"ICG","Cresyl Violet Acetate",{"product_code":348,"device_name":349,"device_class":8,"k510_count":33},"ICI","Hematoxylin, Chrome Alum",{"product_code":351,"device_name":352,"device_class":8,"k510_count":33},"ICM","Brilliant Yellow",{"product_code":354,"device_name":355,"device_class":8,"k510_count":33},"ICO","Best'S Carmine",{"product_code":357,"device_name":358,"device_class":8,"k510_count":33},"ICQ","Azure A",{"product_code":360,"device_name":361,"device_class":8,"k510_count":33},"ICR","Azocarmine B",{"product_code":363,"device_name":364,"device_class":8,"k510_count":33},"ICS","Azocarmine G",{"product_code":366,"device_name":367,"device_class":8,"k510_count":33},"ICT","Azan Counterstain",{"product_code":369,"device_name":370,"device_class":8,"k510_count":33},"ICY","Acid, Aniline, Fuchsin",{"product_code":372,"device_name":373,"device_class":8,"k510_count":33},"ICZ","Ammoniacal Silver Hydroxide Silver Nitrate",{"product_code":375,"device_name":376,"device_class":8,"k510_count":33},"IDB","Aldehyde Fuchsin",{"product_code":378,"device_name":379,"device_class":8,"k510_count":33},"IDD","Alizarin Red",{"product_code":381,"device_name":382,"device_class":8,"k510_count":33},"IDE","Acid, Hematein",{"product_code":384,"device_name":385,"device_class":8,"k510_count":33},"JCH","Esterase",{"product_code":387,"device_name":388,"device_class":8,"k510_count":33},"JCI","Acid Phosphatase, Cytochemical",{"product_code":390,"device_name":391,"device_class":8,"k510_count":33},"KJL","Azure C",{"product_code":393,"device_name":394,"device_class":8,"k510_count":33},"KJM","Bismarck Brown Y",{"product_code":396,"device_name":397,"device_class":8,"k510_count":33},"KJO","Brilliant Green",{"product_code":399,"device_name":400,"device_class":8,"k510_count":33},"KJP","Carmine",{"product_code":402,"device_name":403,"device_class":8,"k510_count":33},"KJQ","Chlorazol Black E",{"product_code":405,"device_name":406,"device_class":8,"k510_count":33},"KJS","Ethyl Eosin",{"product_code":408,"device_name":409,"device_class":8,"k510_count":33},"KJT","Indigocarmine",{"product_code":411,"device_name":412,"device_class":8,"k510_count":33},"KJW","Janus Green B",{"product_code":414,"device_name":415,"device_class":8,"k510_count":33},"KJZ","Martius Yellow",{"product_code":417,"device_name":418,"device_class":8,"k510_count":33},"KKA","Methyl Orange",{"product_code":420,"device_name":421,"device_class":8,"k510_count":33},"KKB","Methyl Violet 2b",{"product_code":423,"device_name":424,"device_class":8,"k510_count":33},"KKC","Methylene Violet",{"product_code":426,"device_name":427,"device_class":8,"k510_count":33},"KKD","Nigrosin",{"product_code":429,"device_name":430,"device_class":8,"k510_count":33},"KKE","Orange Ii",{"product_code":432,"device_name":433,"device_class":8,"k510_count":33},"KKF","Orcein",{"product_code":435,"device_name":436,"device_class":8,"k510_count":33},"KKG","Protargol S",{"product_code":438,"device_name":439,"device_class":8,"k510_count":33},"KKH","Tablet, Resazurin",{"product_code":441,"device_name":442,"device_class":8,"k510_count":33},"KKI","Rose Bengal",{"product_code":444,"device_name":445,"device_class":8,"k510_count":33},"KKL","Thionin",{"product_code":447,"device_name":448,"device_class":8,"k510_count":33},"KKM","Methylene Blue Thiocyanate",{"product_code":450,"device_name":451,"device_class":8,"k510_count":33},"KKP","Solution, Silver Carbonate",{"product_code":453,"device_name":454,"device_class":8,"k510_count":33},"KKQ","Sodium Periodate",{"product_code":456,"device_name":457,"device_class":8,"k510_count":33},"KKR","Potassium Periodate",{"product_code":459,"device_name":460,"device_class":8,"k510_count":33},"KKS","Acid, Periodic",{"product_code":462,"device_name":463,"device_class":8,"k510_count":33},"KKT","Hematoxylin, Ehrlich'S",{"product_code":465,"device_name":466,"device_class":8,"k510_count":33},"KKW","Basic Fuchsin",{"510k":468,"classification":469,"enforcement":470,"event":471,"pma":472,"warning_letter":473},"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":475,"definition_ja":34,"commentary_ja":476,"model_name":477,"source_hash":478,"reviewed_by":34,"reviewed_at":34,"created_at":479,"updated_at":479},"ニュートラルレッド染色用試薬","本品は血球等の細胞成分を染色するために用いられるニュートラルレッド試薬であり、米国ではクラスIに分類される医療機器です。クラスIは相対的にリスクが低い機器に適用される区分であり、本品は510(k)による市販前届出が免除されています。","claude-sonnet-5","64de2cbfef299758e83b0370614e1d505fa840d4bb1359e0be5be2ad46253c22","2026-08-24T02:07:08.607632+00:00",{"product_code":6,"summary_ja":481,"stats":482,"stats_hash":491,"model_name":477,"created_at":492,"updated_at":492},"本製品はクラス I の届出免除品目であり、510(k)の累計件数は1件、参入企業数は1社で、直近5年の届出はありません。不具合報告（MDR）の累計件数は0件で、回収についても累計0件と、いずれの実績も確認されていません。",{"pma":483,"k510":484,"as_of":486,"events":487,"recalls":488,"top_problems":490},{"latest":34,"originals":33,"supplements":33},{"total":35,"last5y":33,"latest":485,"applicants":35},"1987-04-29","2026-08",{"death":33,"other":33,"total":33,"injury":33,"last5y":33,"malfunction":33,"latest_month":34},{"total":33,"last5y":33,"latest":34,"class_i":33,"class_ii":33,"class_iii":33,"top_root_causes":489},[],[],"1cd0b7561546f98a07322046ec12807be312fa22cdcbe636a448179d03ecb075","2026-08-24T04:44:46.948226+00:00",{"items":494,"total":33},[],{"items":496,"total":35},[497],{"k_number":20,"device_name":498,"applicant":499,"decision_date":485,"clearance_type":500,"decision_code":501,"statement_or_summary":34},"NEUTRAL RED","Sigma Chemical Co.","Traditional","SESE",{"items":503,"total":33},[]]