[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GIS":3},{"classification":4,"mappedDevices":51,"similarCandidates":52,"relatedClassifications":124,"syncDates":154},{"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":45,"updated_at":46,"recall_count":47,"latest_recall_date":48,"k510_count":49,"pma_count":47,"event_count":50},4030,"GIS","Test, Fibrinogen","2","864.7340","HE","Hematology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":42,"product_code":6,"review_panel":10,"gmp_exempt_flag":42,"third_party_flag":43,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":42,"medical_specialty_description":11,"summary_malfunction_reporting":44},{"k_number":17,"fei_number":31,"registration_number":39},[18,19,20,21,22,23,24,25,26,27,28,29,30],"K993482","K781880","K963902","K941001","K143470","K910636","K881150","K881685","K913061","K923921","K042919","K925494","K903874",[32,33,34,35,36,37,38],"1000403749","2084025","1181121","3037000637","2431530","3000210416","3004445302",[40,32,33,34,35,36,41],"2032900","1835316","N","Y","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",0,null,13,68,[],[53,61,68,76,83,90,97,105,112,119],{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":47,"vector_similarity":59,"score":60},3361,"汗試験用電極","Ⅰ","11461000",0.15625,0.641093,0.0307692,{"medical_device_id":62,"generic_name":63,"class_classification":56,"jmdn_code":64,"name_similarity":65,"definition_similarity":47,"vector_similarity":66,"score":67},3495,"汗試験用イオン導入装置","15128000",0.138889,0.623392,0.0280063,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":47,"vector_similarity":74,"score":75},1592,"肺機能検査用フィルタ","Ⅱ","70086000",0.139535,0.621851,0.0278638,{"medical_device_id":77,"generic_name":78,"class_classification":56,"jmdn_code":79,"name_similarity":80,"definition_similarity":47,"vector_similarity":81,"score":82},4449,"咀嚼能力検査用物質","71093001",0.130435,0.63295,0.0276506,{"medical_device_id":84,"generic_name":85,"class_classification":56,"jmdn_code":86,"name_similarity":87,"definition_similarity":47,"vector_similarity":88,"score":89},3550,"血液凝固測定装置専用カートリッジ","70185000",0.133333,0.623022,0.0268468,{"medical_device_id":91,"generic_name":92,"class_classification":71,"jmdn_code":93,"name_similarity":94,"definition_similarity":47,"vector_similarity":95,"score":96},2752,"歯科用色調適合確認材料","70845000",0.108696,0.610274,0.0242504,{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":47,"vector_similarity":103,"score":104},286,"細動誘発器","Ⅳ","11700000",0.217391,0.596839,0.0163934,{"medical_device_id":106,"generic_name":107,"class_classification":108,"jmdn_code":109,"name_similarity":110,"definition_similarity":47,"vector_similarity":111,"score":104},1089,"自己検査用血液凝固分析器","Ⅲ","56687003",0.0327869,0.661505,{"medical_device_id":113,"generic_name":114,"class_classification":56,"jmdn_code":115,"name_similarity":116,"definition_similarity":47,"vector_similarity":117,"score":118},3417,"平衡機能計","17242001",0.2,0.590548,0.016129,{"medical_device_id":120,"generic_name":121,"class_classification":56,"jmdn_code":122,"name_similarity":47,"definition_similarity":47,"vector_similarity":123,"score":118},3543,"血液凝固分析装置","35514000",0.651457,[125,129,133,137,141,145,148,151],{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"KQJ","System, Fibrinogen Determination",28,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"GIL","Plasma, Fibrinogen Control",8,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"GFX","Fibrinogen Standard",3,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"DAT","Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control",2,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"GFK","Fibrinogen Determination Standards And Controls",1,{"product_code":146,"device_name":147,"device_class":8,"k510_count":47},"DAR","Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control",{"product_code":149,"device_name":150,"device_class":8,"k510_count":47},"DAX","Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control",{"product_code":152,"device_name":153,"device_class":8,"k510_count":47},"DAZ","Fibrinogen And Split Products, Antigen, Antiserum, Control",{"510k":155,"classification":156,"enforcement":157,"event":158,"pma":159,"warning_letter":160},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]