[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GFX":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":105,"syncDates":134},{"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":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":31,"event_count":34},4900,"GFX","Fibrinogen Standard","2","864.7340","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":17,"fei_number":21,"registration_number":24},[18,19,20],"K812628","K994341","K072304",[22,23],"3001644026","3004445302",[25,26],"2032900","9610806","N","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-18T22:05:38.961415+00:00",0,null,3,2,[],[37,45,52,59,67,72,79,85,93,99],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":31,"vector_similarity":43,"score":44},104,"ヘパリン使用光ファイバオキシメトリー用カテーテル","Ⅳ","31659200",0.0862069,0.600925,0.0269928,{"medical_device_id":46,"generic_name":47,"class_classification":40,"jmdn_code":48,"name_similarity":49,"definition_similarity":31,"vector_similarity":50,"score":51},286,"細動誘発器","11700000",0.185185,0.575714,0.0163934,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":31,"vector_similarity":58,"score":51},1089,"自己検査用血液凝固分析器","Ⅲ","56687003",0.046875,0.630473,{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":31,"vector_similarity":65,"score":66},3243,"X線管支持床支持台","Ⅰ","37076000",0.136364,0.457493,0.016129,{"medical_device_id":68,"generic_name":69,"class_classification":62,"jmdn_code":70,"name_similarity":31,"definition_similarity":31,"vector_similarity":71,"score":66},3543,"血液凝固分析装置","35514000",0.625919,{"medical_device_id":73,"generic_name":74,"class_classification":55,"jmdn_code":75,"name_similarity":76,"definition_similarity":31,"vector_similarity":77,"score":78},735,"ヘパリン使用体外循環用血液学的パラメータモニタ向け測定セル","70528000",0.0105263,0.616558,0.015873,{"medical_device_id":80,"generic_name":81,"class_classification":62,"jmdn_code":82,"name_similarity":83,"definition_similarity":31,"vector_similarity":84,"score":78},4067,"頭部顔面規格写真撮影装置","70734000",0.131148,0.52699,{"medical_device_id":86,"generic_name":87,"class_classification":88,"jmdn_code":89,"name_similarity":90,"definition_similarity":31,"vector_similarity":91,"score":92},2181,"注射筒用フィルタ","Ⅱ","15283000",0.129032,0.459261,0.015625,{"medical_device_id":94,"generic_name":95,"class_classification":62,"jmdn_code":96,"name_similarity":97,"definition_similarity":31,"vector_similarity":98,"score":92},3534,"ヘパリン分析装置","33321000",0.0277778,0.612217,{"medical_device_id":100,"generic_name":101,"class_classification":40,"jmdn_code":102,"name_similarity":57,"definition_similarity":31,"vector_similarity":103,"score":104},92,"ヘパリン使用心臓用カテーテル先端型流量式トランスデューサ","36040204",0.611981,0.0153846,[106,110,114,118,121,125,128,131],{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"KQJ","System, Fibrinogen Determination",28,{"product_code":111,"device_name":112,"device_class":8,"k510_count":113},"GIS","Test, Fibrinogen",13,{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"GIL","Plasma, Fibrinogen Control",8,{"product_code":119,"device_name":120,"device_class":8,"k510_count":34},"DAT","Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control",{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"GFK","Fibrinogen Determination Standards And Controls",1,{"product_code":126,"device_name":127,"device_class":8,"k510_count":31},"DAR","Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control",{"product_code":129,"device_name":130,"device_class":8,"k510_count":31},"DAX","Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control",{"product_code":132,"device_name":133,"device_class":8,"k510_count":31},"DAZ","Fibrinogen And Split Products, Antigen, Antiserum, Control",{"510k":135,"classification":136,"enforcement":137,"event":138,"pma":139,"warning_letter":140},"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"]