[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DFT":3},{"classification":4,"mappedDevices":74,"similarCandidates":75,"relatedClassifications":146,"syncDates":194},{"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":14,"raw":15,"created_at":67,"updated_at":68,"recall_count":69,"latest_recall_date":70,"k510_count":71,"pma_count":72,"event_count":73},6941,"DFT","Igm, Antigen, Antiserum, Control","2","866.5550","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":64,"product_code":6,"review_panel":10,"gmp_exempt_flag":64,"third_party_flag":65,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":64,"medical_specialty_description":11,"summary_malfunction_reporting":66},{"k_number":17,"fei_number":51,"registration_number":63},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"K791402","K831103","K862762","K871498","K803251","K873871","K872237","K894417","K802177","K811124","K962201","K760917","K884147","K853469","K901453","K945522","K855010","K760147","K770963","K830606","K983132","K842327","K841814","K955797","K772254","K800167","K812632","K831608","K760673","K880828","K801282","K832265","K832259",[52,53,54,55,56,57,58,59,60,61,62],"3004493545","2050010","1000403749","3002809144","3016438761","1181121","3000148879","3005094123","3005333358","2050012","1618982",[52,53,54,55,56,57,58,59,60,61,62],"N","Y","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",4,"2022-12-14",33,0,1,[],[76,84,91,99,106,114,120,127,133,140],{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":72,"vector_similarity":82,"score":83},3277,"X線自動露出制御器","Ⅰ","34311000",0.18,0.582346,0.0300905,{"medical_device_id":85,"generic_name":86,"class_classification":79,"jmdn_code":87,"name_similarity":88,"definition_similarity":72,"vector_similarity":89,"score":90},3589,"低温温度制御装置","16538000",0.176471,0.566558,0.0275264,{"medical_device_id":92,"generic_name":93,"class_classification":94,"jmdn_code":95,"name_similarity":96,"definition_similarity":72,"vector_similarity":97,"score":98},456,"注射筒輸液ポンプコントロールユニット","Ⅲ","37217000",0.173077,0.559568,0.0258492,{"medical_device_id":100,"generic_name":101,"class_classification":94,"jmdn_code":102,"name_similarity":103,"definition_similarity":72,"vector_similarity":104,"score":105},692,"透析用監視装置","36424000",0.150943,0.570352,0.0253815,{"medical_device_id":107,"generic_name":108,"class_classification":109,"jmdn_code":110,"name_similarity":111,"definition_similarity":72,"vector_similarity":112,"score":113},2446,"酸素コントローラ","Ⅱ","70577000",0.257143,0.519807,0.0163934,{"medical_device_id":115,"generic_name":116,"class_classification":79,"jmdn_code":117,"name_similarity":118,"definition_similarity":72,"vector_similarity":119,"score":113},3514,"粒子計測免疫測定装置","70181000",0.12069,0.634817,{"medical_device_id":121,"generic_name":122,"class_classification":109,"jmdn_code":123,"name_similarity":124,"definition_similarity":72,"vector_similarity":125,"score":126},2500,"エアパッド加温装置コントロールユニット","36954010",0.195652,0.493745,0.016129,{"medical_device_id":128,"generic_name":129,"class_classification":79,"jmdn_code":130,"name_similarity":131,"definition_similarity":72,"vector_similarity":132,"score":126},3510,"免疫蛍光分析装置","35707010",0.0816327,0.630968,{"medical_device_id":134,"generic_name":135,"class_classification":94,"jmdn_code":136,"name_similarity":137,"definition_similarity":72,"vector_similarity":138,"score":139},459,"医薬品注入コントローラ","11010000",0.186047,0.553074,0.015873,{"medical_device_id":141,"generic_name":142,"class_classification":79,"jmdn_code":143,"name_similarity":144,"definition_similarity":72,"vector_similarity":145,"score":139},3511,"移動式免疫蛍光分析装置","35707020",0.0714286,0.621433,[147,151,155,159,163,166,169,173,176,179,182,185,188,191],{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"DFH","Kappa, Antigen, Antiserum, Control",63,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"DEH","Lambda, Antigen, Antiserum, Control",53,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"DAO","Igm (Mu Chain Specific), Antigen, Antiserum, Control",8,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"DEY","Igm, Peroxidase, Antigen, Antiserum, Control",3,{"product_code":164,"device_name":165,"device_class":8,"k510_count":162},"DFD","Kappa, Peroxidase, Antigen, Antiserum, Control",{"product_code":167,"device_name":168,"device_class":8,"k510_count":162},"DFL","Igm, Ferritin, Antigen, Antiserum, Control",{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"DEO","Kappa, Fitc, Antigen, Antiserum, Control",2,{"product_code":174,"device_name":175,"device_class":8,"k510_count":172},"DES","Lambda, Fitc, Antigen, Antiserum, Control",{"product_code":177,"device_name":178,"device_class":8,"k510_count":172},"LYE","Cytokeratins",{"product_code":180,"device_name":181,"device_class":8,"k510_count":73},"DEP","Lambda, Peroxidase, Antigen, Antiserum, Control",{"product_code":183,"device_name":184,"device_class":8,"k510_count":73},"DFG","Lambda, Rhodamine, Antigen, Antiserum, Control",{"product_code":186,"device_name":187,"device_class":8,"k510_count":73},"DFS","Igm, Fitc, Antigen, Antiserum, Control",{"product_code":189,"device_name":190,"device_class":8,"k510_count":72},"DEK","Kappa, Rhodamine, Antigen, Antiserum, Control",{"product_code":192,"device_name":193,"device_class":8,"k510_count":72},"DEZ","Igm, Rhodamine, Antigen, Antiserum, Control",{"510k":195,"classification":196,"enforcement":197,"event":198,"pma":199,"warning_letter":200},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]