[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-CHN":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":114,"syncDates":131},{"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":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":38,"event_count":39},5611,"CHN","Immunochemical, Ceruloplasmin","2","866.5210","IM","Immunology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"k_number":17,"fei_number":21,"registration_number":27},[18,19,20],"K063655","K062114","K091741",[22,23,24,25,26],"3003795116","3001644026","3006198300","3002806559","3002806560",[28,22,29,30,24],"9610126","9610806","9610529","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",6,"2017-12-06",3,0,2,[],[42,50,57,64,71,78,85,92,99,107],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":38,"vector_similarity":48,"score":49},3556,"イムノアッセイ用シンチレーションカウンタ","Ⅰ","34567000",0.125,0.601764,0.029236,{"medical_device_id":51,"generic_name":52,"class_classification":45,"jmdn_code":53,"name_similarity":54,"definition_similarity":38,"vector_similarity":55,"score":56},3512,"免疫発光測定装置","36223010",0.196429,0.577766,0.0290517,{"medical_device_id":58,"generic_name":59,"class_classification":45,"jmdn_code":60,"name_similarity":61,"definition_similarity":38,"vector_similarity":62,"score":63},3510,"免疫蛍光分析装置","35707010",0.12,0.602014,0.0290309,{"medical_device_id":65,"generic_name":66,"class_classification":45,"jmdn_code":67,"name_similarity":68,"definition_similarity":38,"vector_similarity":69,"score":70},3513,"移動式免疫発光測定装置","36223020",0.174603,0.576138,0.0283242,{"medical_device_id":72,"generic_name":73,"class_classification":45,"jmdn_code":74,"name_similarity":75,"definition_similarity":38,"vector_similarity":76,"score":77},3514,"粒子計測免疫測定装置","70181000",0.114754,0.632512,0.0281581,{"medical_device_id":79,"generic_name":80,"class_classification":45,"jmdn_code":81,"name_similarity":82,"definition_similarity":38,"vector_similarity":83,"score":84},3508,"免疫比濁分析装置","35926010",0.115385,0.601888,0.0276732,{"medical_device_id":86,"generic_name":87,"class_classification":45,"jmdn_code":88,"name_similarity":89,"definition_similarity":38,"vector_similarity":90,"score":91},3511,"移動式免疫蛍光分析装置","35707020",0.105263,0.601804,0.0267483,{"medical_device_id":93,"generic_name":94,"class_classification":45,"jmdn_code":95,"name_similarity":96,"definition_similarity":38,"vector_similarity":97,"score":98},3505,"酵素免疫測定装置","35706010",0.117647,0.573213,0.0243148,{"medical_device_id":100,"generic_name":101,"class_classification":102,"jmdn_code":103,"name_similarity":104,"definition_similarity":38,"vector_similarity":105,"score":106},393,"ヘパリン使用血管留置用センサ","Ⅲ","70273000",0.0441176,0.606456,0.016129,{"medical_device_id":108,"generic_name":109,"class_classification":45,"jmdn_code":110,"name_similarity":111,"definition_similarity":38,"vector_similarity":112,"score":113},3710,"子宮頚管拡張器","70344000",0.15,0.415291,0.015873,[115,119,122,125,128],{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"DDB","Ceruloplasmin, Antigen, Antiserum, Control",19,{"product_code":120,"device_name":121,"device_class":8,"k510_count":39},"JFR","Indirect Copper Assay, Ceruloplasmin",{"product_code":123,"device_name":124,"device_class":8,"k510_count":38},"DCT","Ceruloplasmin, Rhodamine, Antigen, Antiserum, Control",{"product_code":126,"device_name":127,"device_class":8,"k510_count":38},"DCY","Ceruloplasmin, Fitc, Antigen, Antiserum, Control",{"product_code":129,"device_name":130,"device_class":8,"k510_count":38},"JFQ","P-Phenyl-Enediamine\u002FEdta (Spectrophotometric), Ceruloplasmin",{"510k":132,"classification":133,"enforcement":134,"event":135,"pma":136,"warning_letter":137},"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"]