[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LEW":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":98,"syncDates":119},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":24},1568,"LEW","Thin Layer Chromatography, Theophylline","2","862.3880","TX","Clinical Toxicology","1","",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":20,"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":21},{"k_number":17},[18],"K771120","N","Y","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[29,37,44,52,59,65,72,78,85,91],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":24,"vector_similarity":35,"score":36},3518,"高速液体クロマトグラフィ分析装置","Ⅰ","36420000",0.253731,0.606369,0.0325225,{"medical_device_id":38,"generic_name":39,"class_classification":32,"jmdn_code":40,"name_similarity":41,"definition_similarity":24,"vector_similarity":42,"score":43},3524,"カテコールアミン分析装置","35989000",0.0526316,0.632718,0.0163934,{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":24,"vector_similarity":50,"score":51},1924,"胆管造影用カテーテル","Ⅱ","16429000",0.2,0.495858,0.016129,{"medical_device_id":53,"generic_name":54,"class_classification":47,"jmdn_code":55,"name_similarity":56,"definition_similarity":24,"vector_similarity":57,"score":58},2080,"X線用子宮カテーテル","18746000",0.192982,0.501714,0.015873,{"medical_device_id":60,"generic_name":61,"class_classification":32,"jmdn_code":62,"name_similarity":63,"definition_similarity":24,"vector_similarity":64,"score":58},3503,"デンシトメトリー分析装置","15129000",0.0175439,0.592358,{"medical_device_id":66,"generic_name":67,"class_classification":47,"jmdn_code":68,"name_similarity":69,"definition_similarity":24,"vector_similarity":70,"score":71},2024,"唾液腺造影用カテーテル","70278000",0.1875,0.509695,0.015625,{"medical_device_id":73,"generic_name":74,"class_classification":32,"jmdn_code":75,"name_similarity":76,"definition_similarity":24,"vector_similarity":77,"score":71},3523,"グリコヘモグロビン分析装置","35968000",0.0338983,0.591725,{"medical_device_id":79,"generic_name":80,"class_classification":47,"jmdn_code":81,"name_similarity":82,"definition_similarity":24,"vector_similarity":83,"score":84},1386,"色素希釈心拍出量計","16177000",0.0149254,0.58468,0.0153846,{"medical_device_id":86,"generic_name":87,"class_classification":32,"jmdn_code":88,"name_similarity":89,"definition_similarity":24,"vector_similarity":90,"score":84},3264,"液晶サーモグラフィシート","40798001",0.186441,0.531807,{"medical_device_id":92,"generic_name":93,"class_classification":47,"jmdn_code":94,"name_similarity":95,"definition_similarity":24,"vector_similarity":96,"score":97},1350,"サーモグラフィ装置オペレータ用コンソール","40972000",0.177419,0.424428,0.0151515,[99,103,107,111,115],{"product_code":100,"device_name":101,"device_class":8,"k510_count":102},"KLS","Enzyme Immunoassay, Theophylline",71,{"product_code":104,"device_name":105,"device_class":8,"k510_count":106},"LER","Fluorescent Immunoassay, Theophylline",15,{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"LGS","Fluorescence Polarization Immunoassay, Theophylline",13,{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"LCA","Radioimmunoassay, Theophylline",5,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"LCY","U.V. Spectrometry, Theophylline",3,{"510k":120,"classification":121,"enforcement":122,"event":123,"pma":124,"warning_letter":125},"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"]