[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LBA":3},{"classification":4,"mappedDevices":26,"similarCandidates":27,"relatedClassifications":98,"syncDates":134},{"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":21,"updated_at":22,"recall_count":23,"latest_recall_date":24,"k510_count":25,"pma_count":23,"event_count":23},6947,"LBA","Procainamide Control Materials","1","862.3280","TX","Clinical Toxicology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":10,"gmp_exempt_flag":19,"third_party_flag":19,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":20},{"k_number":17},[18],"K833227","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[28,36,44,51,58,64,71,78,85,91],{"medical_device_id":29,"generic_name":30,"class_classification":31,"jmdn_code":32,"name_similarity":33,"definition_similarity":23,"vector_similarity":34,"score":35},967,"物質併用処置用能動器具","Ⅲ","70668000",0.222222,0.598522,0.0310096,{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":23,"vector_similarity":42,"score":43},2487,"ウォーターパッド加温装置コントロールユニット","Ⅱ","36956010",0.215686,0.581945,0.0273466,{"medical_device_id":45,"generic_name":46,"class_classification":31,"jmdn_code":47,"name_similarity":48,"definition_similarity":23,"vector_similarity":49,"score":50},1023,"医薬品含有歯科裏層用高分子系材料","70863003",0.197183,0.577941,0.0239943,{"medical_device_id":52,"generic_name":53,"class_classification":31,"jmdn_code":54,"name_similarity":55,"definition_similarity":23,"vector_similarity":56,"score":57},1017,"医薬品含有歯科用覆髄材料","70852000",0.25,0.537862,0.0163934,{"medical_device_id":59,"generic_name":60,"class_classification":39,"jmdn_code":61,"name_similarity":62,"definition_similarity":23,"vector_similarity":63,"score":57},2556,"トレパンシステムコントロールユニット","43928000",0.153846,0.612442,{"medical_device_id":65,"generic_name":66,"class_classification":31,"jmdn_code":67,"name_similarity":68,"definition_similarity":23,"vector_similarity":69,"score":70},1125,"植込み能動型機器管理用プログラム","71052003",0.117647,0.604902,0.016129,{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":76,"definition_similarity":23,"vector_similarity":77,"score":70},3799,"ギプス包帯","Ⅰ","33056000",0.23913,0.42833,{"medical_device_id":79,"generic_name":80,"class_classification":31,"jmdn_code":81,"name_similarity":82,"definition_similarity":23,"vector_similarity":83,"score":84},661,"体内用合成・炭素繊維補綴材","33473103",0.0555556,0.60487,0.015873,{"medical_device_id":86,"generic_name":87,"class_classification":31,"jmdn_code":88,"name_similarity":89,"definition_similarity":23,"vector_similarity":90,"score":84},1018,"医薬品含有歯科用充填材料キット","70853003",0.22807,0.519841,{"medical_device_id":92,"generic_name":93,"class_classification":31,"jmdn_code":94,"name_similarity":95,"definition_similarity":23,"vector_similarity":96,"score":97},519,"非吸収性ステープルライン補強材料","70435000",0.0379747,0.599565,0.015625,[99,103,107,111,115,119,122,125,128,131],{"product_code":100,"device_name":101,"device_class":8,"k510_count":102},"DIF","Drug Mixture Control Materials",202,{"product_code":104,"device_name":105,"device_class":8,"k510_count":106},"LAS","Drug Specific Control Materials",83,{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"DKC","Alcohol Control Materials",11,{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"DIE","Heavy Metals Control Materials",5,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"DMP","Digoxin Control Serum, Ria",4,{"product_code":120,"device_name":121,"device_class":8,"k510_count":118},"LAW","Theophylline Control Materials",{"product_code":123,"device_name":124,"device_class":8,"k510_count":118},"LAZ","N-Acetylprocainamide Control Materials",{"product_code":126,"device_name":127,"device_class":8,"k510_count":25},"DJK","Digitoxin Control Serum, Ria",{"product_code":129,"device_name":130,"device_class":8,"k510_count":25},"LAX","Lidocaine Control Materials",{"product_code":132,"device_name":133,"device_class":8,"k510_count":23},"LAY","Methotrexate Control Materials",{"510k":135,"classification":136,"enforcement":137,"event":138,"pma":139,"warning_letter":140},"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","2026-08-18T06:42:29.411+00:00"]