[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DFC":3},{"classification":4,"mappedDevices":109,"similarCandidates":110,"relatedClassifications":181,"syncDates":190},{"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":102,"updated_at":103,"recall_count":104,"latest_recall_date":105,"k510_count":106,"pma_count":107,"event_count":108},1734,"DFC","Lipoprotein, Low-Density, Antigen, Antiserum, Control","2","866.5600","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":99,"product_code":6,"review_panel":10,"gmp_exempt_flag":99,"third_party_flag":100,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":99,"medical_specialty_description":11,"summary_malfunction_reporting":101},{"k_number":17,"fei_number":61,"registration_number":88},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60],"K993669","K872080","K241220","K013206","K883711","K050487","K063838","K253069","K023853","K992665","K001933","K013207","K954657","K013128","K983281","K180074","K771812","K013359","K001919","K781015","K994110","K000121","K001920","K082488","K123046","K980812","K904137","K001921","K211058","K883712","K001929","K990595","K021660","K001118","K001934","K771912","K001931","K982708","K122722","K903122","K970302","K981446","K923079",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87],"3002806557","3002808140","3003795116","1827821","3000303338","3002809144","3014607865","3016438761","2432235","3005094123","2050012","1318354","2050010","1000206808","2084025","1181121","3005333358","3002806560","3004493545","1000403749","3001644026","3006198300","3002806559","3004445302","1000306617","1000135102",[64,65,89,90,67,68,69,70,71,72,91,73,92,74,76,77,93,94,95,78,96,97,80,81,98,83],"9610529","2029372","2032900","9610126","9610806","9610746","9681753","9680746","8032314","2085064","N","Y","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",6,"2025-01-29",43,0,37,[],[111,119,126,134,141,148,154,161,168,175],{"medical_device_id":112,"generic_name":113,"class_classification":114,"jmdn_code":115,"name_similarity":116,"definition_similarity":107,"vector_similarity":117,"score":118},1125,"植込み能動型機器管理用プログラム","Ⅲ","71052003",0.153846,0.559716,0.0258564,{"medical_device_id":120,"generic_name":121,"class_classification":114,"jmdn_code":122,"name_similarity":123,"definition_similarity":107,"vector_similarity":124,"score":125},718,"人工心肺用ガスコントロールユニット","31714000",0.126761,0.57164,0.0257937,{"medical_device_id":127,"generic_name":128,"class_classification":129,"jmdn_code":130,"name_similarity":131,"definition_similarity":107,"vector_similarity":132,"score":133},2251,"局所管理フォーム状創傷被覆・保護材","Ⅱ","11323002",0.177419,0.522281,0.0163934,{"medical_device_id":135,"generic_name":136,"class_classification":137,"jmdn_code":138,"name_similarity":139,"definition_similarity":107,"vector_similarity":140,"score":133},3521,"コレステロール分析装置","Ⅰ","30855000",0.1,0.619128,{"medical_device_id":142,"generic_name":143,"class_classification":137,"jmdn_code":144,"name_similarity":145,"definition_similarity":107,"vector_similarity":146,"score":147},3504,"蛋白質分析装置","30857000",0.169811,0.518867,0.016129,{"medical_device_id":149,"generic_name":150,"class_classification":137,"jmdn_code":151,"name_similarity":152,"definition_similarity":107,"vector_similarity":153,"score":147},3514,"粒子計測免疫測定装置","70181000",0.0769231,0.608724,{"medical_device_id":155,"generic_name":156,"class_classification":114,"jmdn_code":157,"name_similarity":158,"definition_similarity":107,"vector_similarity":159,"score":160},808,"能動型機器接続用酸素濃縮器","12873003",0.169231,0.499603,0.015873,{"medical_device_id":162,"generic_name":163,"class_classification":164,"jmdn_code":165,"name_similarity":166,"definition_similarity":107,"vector_similarity":167,"score":160},1156,"マウス抗体使用冠動脈ステント","Ⅳ","47826004",0.08,0.606986,{"medical_device_id":169,"generic_name":170,"class_classification":114,"jmdn_code":171,"name_similarity":172,"definition_similarity":107,"vector_similarity":173,"score":174},474,"ヘパリン使用成分採血セット","70405000",0.0571429,0.59013,0.015625,{"medical_device_id":176,"generic_name":177,"class_classification":129,"jmdn_code":178,"name_similarity":179,"definition_similarity":107,"vector_similarity":180,"score":174},2660,"歯科非鋳造用低カラット金合金","70772000",0.169014,0.50268,[182,186],{"product_code":183,"device_name":184,"device_class":8,"k510_count":185},"NOE","Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2",8,{"product_code":187,"device_name":188,"device_class":8,"k510_count":189},"NTV","Myeloperoxidase, Immunoassay, System, Test",2,{"510k":191,"classification":192,"enforcement":193,"event":194,"pma":195,"warning_letter":196},"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"]