[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DER":3},{"classification":4,"mappedDevices":60,"similarCandidates":61,"relatedClassifications":132,"syncDates":133},{"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":53,"updated_at":54,"recall_count":55,"latest_recall_date":56,"k510_count":57,"pma_count":58,"event_count":59},5200,"DER","Alpha-1-Lipoprotein, Antigen, Antiserum, Control","2","866.5580","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":50,"product_code":6,"review_panel":10,"gmp_exempt_flag":50,"third_party_flag":51,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":50,"medical_specialty_description":11,"summary_malfunction_reporting":52},{"k_number":17,"fei_number":35,"registration_number":47},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34],"K000921","K910553","K854875","K853048","K904125","K851649","K802610","K964296","K983289","K840830","K872078","K964292","K964294","K990594","K993354","K993345","K013249",[36,37,38,39,40,41,42,43,44,45,46],"1000403749","3002809144","3003795116","3016438761","2084025","1181121","3005094123","3006198300","3005333358","3002806559","3002806560",[48,36,37,38,39,40,41,49,42,43,44],"9610126","9610529","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",2,"2019-07-31",17,0,3,[],[62,70,78,84,92,98,105,111,118,124],{"medical_device_id":63,"generic_name":64,"class_classification":65,"jmdn_code":66,"name_similarity":67,"definition_similarity":58,"vector_similarity":68,"score":69},3277,"X線自動露出制御器","Ⅰ","34311000",0.138462,0.574784,0.028624,{"medical_device_id":71,"generic_name":72,"class_classification":73,"jmdn_code":74,"name_similarity":75,"definition_similarity":58,"vector_similarity":76,"score":77},1156,"マウス抗体使用冠動脈ステント","Ⅳ","47826004",0.084507,0.612722,0.0163934,{"medical_device_id":79,"generic_name":80,"class_classification":65,"jmdn_code":81,"name_similarity":82,"definition_similarity":58,"vector_similarity":83,"score":77},3504,"蛋白質分析装置","30857000",0.183673,0.526477,{"medical_device_id":85,"generic_name":86,"class_classification":87,"jmdn_code":88,"name_similarity":89,"definition_similarity":58,"vector_similarity":90,"score":91},2446,"酸素コントローラ","Ⅱ","70577000",0.18,0.515182,0.016129,{"medical_device_id":93,"generic_name":94,"class_classification":65,"jmdn_code":95,"name_similarity":96,"definition_similarity":58,"vector_similarity":97,"score":91},3521,"コレステロール分析装置","30855000",0.107143,0.611717,{"medical_device_id":99,"generic_name":100,"class_classification":87,"jmdn_code":101,"name_similarity":102,"definition_similarity":58,"vector_similarity":103,"score":104},2251,"局所管理フォーム状創傷被覆・保護材","11323002",0.15,0.503822,0.015873,{"medical_device_id":106,"generic_name":107,"class_classification":65,"jmdn_code":108,"name_similarity":109,"definition_similarity":58,"vector_similarity":110,"score":104},3514,"粒子計測免疫測定装置","70181000",0.0810811,0.604062,{"medical_device_id":112,"generic_name":113,"class_classification":87,"jmdn_code":114,"name_similarity":115,"definition_similarity":58,"vector_similarity":116,"score":117},2500,"エアパッド加温装置コントロールユニット","36954010",0.147541,0.496735,0.015625,{"medical_device_id":119,"generic_name":120,"class_classification":65,"jmdn_code":121,"name_similarity":122,"definition_similarity":58,"vector_similarity":123,"score":117},3511,"移動式免疫蛍光分析装置","35707020",0.0416667,0.597654,{"medical_device_id":125,"generic_name":126,"class_classification":127,"jmdn_code":128,"name_similarity":129,"definition_similarity":58,"vector_similarity":130,"score":131},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","Ⅲ","70528000",0.0263158,0.592459,0.0153846,[],{"510k":134,"classification":135,"enforcement":136,"event":137,"pma":138,"warning_letter":139},"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"]