[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DEY":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":104,"syncDates":152},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":28,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":32,"pma_count":30,"event_count":33},7045,"DEY","Igm, Peroxidase, Antigen, Antiserum, Control","2","866.5550","IM","Immunology","PA","1","",false,{"openfda":17,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":12,"gmp_exempt_flag":25,"third_party_flag":26,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":27},{"k_number":18,"fei_number":22,"registration_number":24},[19,20,21],"K920600","K920566","K932386",[23],"3019906",[23],"N","Y","Eligible","2026-08-18T05:52:53.878886+00:00","2026-08-18T22:05:38.961415+00:00",0,null,3,1,[],[36,44,51,58,64,71,77,85,91,98],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":30,"vector_similarity":42,"score":43},2446,"酸素コントローラ","Ⅱ","70577000",0.195652,0.534402,0.0163934,{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":30,"vector_similarity":50,"score":43},3510,"免疫蛍光分析装置","Ⅰ","35707010",0.0666667,0.633378,{"medical_device_id":52,"generic_name":53,"class_classification":39,"jmdn_code":54,"name_similarity":55,"definition_similarity":30,"vector_similarity":56,"score":57},2500,"エアパッド加温装置コントロールユニット","36954010",0.178571,0.474693,0.016129,{"medical_device_id":59,"generic_name":60,"class_classification":47,"jmdn_code":61,"name_similarity":62,"definition_similarity":30,"vector_similarity":63,"score":57},3514,"粒子計測免疫測定装置","70181000",0.117647,0.627629,{"medical_device_id":65,"generic_name":66,"class_classification":47,"jmdn_code":67,"name_similarity":68,"definition_similarity":30,"vector_similarity":69,"score":70},3511,"移動式免疫蛍光分析装置","35707020",0.0597015,0.624338,0.015873,{"medical_device_id":72,"generic_name":73,"class_classification":47,"jmdn_code":74,"name_similarity":75,"definition_similarity":30,"vector_similarity":76,"score":70},3589,"低温温度制御装置","16538000",0.163934,0.54491,{"medical_device_id":78,"generic_name":79,"class_classification":80,"jmdn_code":81,"name_similarity":82,"definition_similarity":30,"vector_similarity":83,"score":84},454,"患者管理無痛法用輸液ポンプ","Ⅲ","35932000",0.161765,0.511681,0.015625,{"medical_device_id":86,"generic_name":87,"class_classification":47,"jmdn_code":88,"name_similarity":89,"definition_similarity":30,"vector_similarity":90,"score":84},3506,"移動式酵素免疫測定装置","35706020",0.0588235,0.617013,{"medical_device_id":92,"generic_name":93,"class_classification":80,"jmdn_code":94,"name_similarity":95,"definition_similarity":30,"vector_similarity":96,"score":97},456,"注射筒輸液ポンプコントロールユニット","37217000",0.16129,0.549179,0.0153846,{"medical_device_id":99,"generic_name":100,"class_classification":47,"jmdn_code":101,"name_similarity":102,"definition_similarity":30,"vector_similarity":103,"score":97},3505,"酵素免疫測定装置","35706010",0.0655738,0.604587,[105,109,113,117,121,124,127,131,134,137,140,143,146,149],{"product_code":106,"device_name":107,"device_class":8,"k510_count":108},"DFH","Kappa, Antigen, Antiserum, Control",63,{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"DEH","Lambda, Antigen, Antiserum, Control",53,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"DFT","Igm, Antigen, Antiserum, Control",33,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"DAO","Igm (Mu Chain Specific), Antigen, Antiserum, Control",8,{"product_code":122,"device_name":123,"device_class":8,"k510_count":32},"DFD","Kappa, Peroxidase, Antigen, Antiserum, Control",{"product_code":125,"device_name":126,"device_class":8,"k510_count":32},"DFL","Igm, Ferritin, Antigen, Antiserum, Control",{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"DEO","Kappa, Fitc, Antigen, Antiserum, Control",2,{"product_code":132,"device_name":133,"device_class":8,"k510_count":130},"DES","Lambda, Fitc, Antigen, Antiserum, Control",{"product_code":135,"device_name":136,"device_class":8,"k510_count":130},"LYE","Cytokeratins",{"product_code":138,"device_name":139,"device_class":8,"k510_count":33},"DEP","Lambda, Peroxidase, Antigen, Antiserum, Control",{"product_code":141,"device_name":142,"device_class":8,"k510_count":33},"DFG","Lambda, Rhodamine, Antigen, Antiserum, Control",{"product_code":144,"device_name":145,"device_class":8,"k510_count":33},"DFS","Igm, Fitc, Antigen, Antiserum, Control",{"product_code":147,"device_name":148,"device_class":8,"k510_count":30},"DEK","Kappa, Rhodamine, Antigen, Antiserum, Control",{"product_code":150,"device_name":151,"device_class":8,"k510_count":30},"DEZ","Igm, Rhodamine, Antigen, Antiserum, Control",{"510k":153,"classification":154,"enforcement":155,"event":156,"pma":157,"warning_letter":158},"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"]