[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DAY":3},{"classification":4,"mappedDevices":35,"similarCandidates":36,"relatedClassifications":105,"syncDates":135},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":32,"event_count":32},175,"DAY","Complement C5, Antigen, Antiserum, Control","2","866.5240","IM","Immunology","1","",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":28,"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":29},{"k_number":17,"fei_number":21,"registration_number":25},[18,19,20],"K772075","K942326","K950102",[22,23,24],"3012471076","3002808340","3019906",[22,24,26],"9614373","N","Y","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-18T22:05:38.961415+00:00",0,null,3,[],[37,45,52,59,65,72,78,85,92,99],{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":32,"vector_similarity":43,"score":44},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",0.0186916,0.609807,0.0163934,{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":32,"vector_similarity":51,"score":44},2446,"酸素コントローラ","Ⅱ","70577000",0.214286,0.504284,{"medical_device_id":53,"generic_name":54,"class_classification":40,"jmdn_code":55,"name_similarity":56,"definition_similarity":32,"vector_similarity":57,"score":58},474,"ヘパリン使用成分採血セット","70405000",0.0508475,0.591121,0.016129,{"medical_device_id":60,"generic_name":61,"class_classification":48,"jmdn_code":62,"name_similarity":63,"definition_similarity":32,"vector_similarity":64,"score":58},1607,"コンピュータ制御オージオメータ","41187000",0.2,0.486813,{"medical_device_id":66,"generic_name":67,"class_classification":40,"jmdn_code":68,"name_similarity":69,"definition_similarity":32,"vector_similarity":70,"score":71},393,"ヘパリン使用血管留置用センサ","70273000",0.0273973,0.581068,0.015873,{"medical_device_id":73,"generic_name":74,"class_classification":48,"jmdn_code":75,"name_similarity":76,"definition_similarity":32,"vector_similarity":77,"score":71},2383,"左心室ライン吸引コントロール用バルブ","17581000",0.178571,0.507808,{"medical_device_id":79,"generic_name":80,"class_classification":40,"jmdn_code":81,"name_similarity":82,"definition_similarity":32,"vector_similarity":83,"score":84},454,"患者管理無痛法用輸液ポンプ","35932000",0.171875,0.477112,0.015625,{"medical_device_id":86,"generic_name":87,"class_classification":88,"jmdn_code":89,"name_similarity":90,"definition_similarity":32,"vector_similarity":91,"score":84},3514,"粒子計測免疫測定装置","Ⅰ","70181000",0.0909091,0.578689,{"medical_device_id":93,"generic_name":94,"class_classification":40,"jmdn_code":95,"name_similarity":96,"definition_similarity":32,"vector_similarity":97,"score":98},730,"ヘパリン使用人工心肺用ライン内血液ガスセンサ","31715200",0.0238095,0.577182,0.0153846,{"medical_device_id":100,"generic_name":101,"class_classification":48,"jmdn_code":102,"name_similarity":103,"definition_similarity":32,"vector_similarity":104,"score":98},2500,"エアパッド加温装置コントロールユニット","36954010",0.169811,0.45576,[106,110,114,118,122,126,129,132],{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"CZW","Complement C3, Antigen, Antiserum, Control",44,{"product_code":111,"device_name":112,"device_class":8,"k510_count":113},"DBI","Complement C4, Antigen, Antiserum, Control",34,{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"DAK","Complement C1q, Antigen, Antiserum, Control",28,{"product_code":119,"device_name":120,"device_class":8,"k510_count":121},"DAE","Complement C9, Antigen, Antiserum, Control",6,{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"CZY","Complement C1s, Antigen, Antiserum, Control",1,{"product_code":127,"device_name":128,"device_class":8,"k510_count":32},"DAG","Complement C8, Antigen, Antiserum, Control",{"product_code":130,"device_name":131,"device_class":8,"k510_count":32},"DAI","Complement C1r, Antigen, Antiserum, Control",{"product_code":133,"device_name":134,"device_class":8,"k510_count":32},"KTM","C3-Indirect Immunofluorescent Solid Phase",{"510k":136,"classification":137,"enforcement":138,"event":139,"pma":140,"warning_letter":141},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]