[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DBK":3},{"classification":4,"mappedDevices":24,"similarCandidates":25,"relatedClassifications":96,"syncDates":111},{"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":19,"updated_at":20,"recall_count":21,"latest_recall_date":22,"k510_count":21,"pma_count":21,"event_count":23},4469,"DBK","Fc, Fitc, Antigen, Antiserum, Control","1","866.5530","IM","Immunology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":17,"product_code":6,"review_panel":10,"gmp_exempt_flag":17,"third_party_flag":17,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":17,"medical_specialty_description":11,"summary_malfunction_reporting":18},{},"N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[26,34,42,49,56,63,70,76,83,89],{"medical_device_id":27,"generic_name":28,"class_classification":29,"jmdn_code":30,"name_similarity":31,"definition_similarity":21,"vector_similarity":32,"score":33},3589,"低温温度制御装置","Ⅰ","16538000",0.166667,0.594437,0.0307765,{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":21,"vector_similarity":40,"score":41},718,"人工心肺用ガスコントロールユニット","Ⅲ","31714000",0.142857,0.600552,0.0283242,{"medical_device_id":43,"generic_name":44,"class_classification":29,"jmdn_code":45,"name_similarity":46,"definition_similarity":21,"vector_similarity":47,"score":48},3277,"X線自動露出制御器","34311000",0.169811,0.575421,0.0282051,{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":31,"definition_similarity":21,"vector_similarity":54,"score":55},2480,"天蓋加温装置コントロールユニット","Ⅱ","36953000",0.574345,0.0275836,{"medical_device_id":57,"generic_name":58,"class_classification":37,"jmdn_code":59,"name_similarity":60,"definition_similarity":21,"vector_similarity":61,"score":62},1125,"植込み能動型機器管理用プログラム","71052003",0.174603,0.567989,0.026861,{"medical_device_id":64,"generic_name":65,"class_classification":52,"jmdn_code":66,"name_similarity":67,"definition_similarity":21,"vector_similarity":68,"score":69},2174,"輸液セット用コントローラ","36244000",0.137931,0.577757,0.0248276,{"medical_device_id":71,"generic_name":72,"class_classification":37,"jmdn_code":73,"name_similarity":39,"definition_similarity":21,"vector_similarity":74,"score":75},456,"注射筒輸液ポンプコントロールユニット","37217000",0.571253,0.0238129,{"medical_device_id":77,"generic_name":78,"class_classification":52,"jmdn_code":79,"name_similarity":80,"definition_similarity":21,"vector_similarity":81,"score":82},2446,"酸素コントローラ","70577000",0.236842,0.562689,0.0163934,{"medical_device_id":84,"generic_name":85,"class_classification":29,"jmdn_code":86,"name_similarity":87,"definition_similarity":21,"vector_similarity":88,"score":82},3514,"粒子計測免疫測定装置","70181000",0.0967742,0.62447,{"medical_device_id":90,"generic_name":91,"class_classification":52,"jmdn_code":92,"name_similarity":93,"definition_similarity":21,"vector_similarity":94,"score":95},2251,"局所管理フォーム状創傷被覆・保護材","11323002",0.1875,0.5147,0.016129,[97,101,105,108],{"product_code":98,"device_name":99,"device_class":8,"k510_count":100},"DAS","Igg (Fc Fragment Specific), Antigen, Antiserum, Control",8,{"product_code":102,"device_name":103,"device_class":8,"k510_count":104},"KTO","Reagent, Immunoassay, Igg",2,{"product_code":106,"device_name":107,"device_class":8,"k510_count":23},"DBN","Fc, Antigen, Antiserum, Control",{"product_code":109,"device_name":110,"device_class":8,"k510_count":21},"DBH","Fc, Rhodamine, Antigen, Antiserum, Control",{"510k":112,"classification":113,"enforcement":114,"event":115,"pma":116,"warning_letter":117},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]