[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GMT":3},{"classification":4,"mappedDevices":41,"similarCandidates":42,"relatedClassifications":110,"syncDates":138},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":40},6748,"GMT","Antigens, Ha, Treponema Pallidum","2","866.3830","MI","Microbiology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":32,"product_code":6,"review_panel":10,"gmp_exempt_flag":32,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":32,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"k_number":17,"fei_number":27,"registration_number":31},[18,19,20,21,22,23,24,25,26],"K905038","K911640","K760098","K791457","K893124","K911266","K791897","K971502","K896410",[28,29,30],"1643621","3014328219","3014643041",[28,29,30],"N","Y","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",0,null,9,3,[],[43,51,57,65,71,78,84,91,97,104],{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":37,"vector_similarity":49,"score":50},3514,"粒子計測免疫測定装置","Ⅰ","70181000",0.0769231,0.568443,0.0163934,{"medical_device_id":52,"generic_name":53,"class_classification":46,"jmdn_code":54,"name_similarity":55,"definition_similarity":37,"vector_similarity":56,"score":50},4175,"骨トレパン","14147000",0.128205,0.47229,{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":37,"vector_similarity":63,"score":64},2654,"歯科用パラジウム地金","Ⅱ","70766000",0.12,0.43081,0.016129,{"medical_device_id":66,"generic_name":67,"class_classification":46,"jmdn_code":68,"name_similarity":69,"definition_similarity":37,"vector_similarity":70,"score":64},3569,"血液型分析装置","35635000",0.0806452,0.540778,{"medical_device_id":72,"generic_name":73,"class_classification":74,"jmdn_code":75,"name_similarity":37,"definition_similarity":37,"vector_similarity":76,"score":77},1166,"マラリア診断装置","Ⅲ","71081003",0.538767,0.015873,{"medical_device_id":79,"generic_name":80,"class_classification":60,"jmdn_code":81,"name_similarity":82,"definition_similarity":37,"vector_similarity":83,"score":77},1634,"定量的感覚検査用パルポメータ","40817000",0.114754,0.484817,{"medical_device_id":85,"generic_name":86,"class_classification":46,"jmdn_code":87,"name_similarity":88,"definition_similarity":37,"vector_similarity":89,"score":90},3509,"移動式免疫比濁分析装置","35926020",0.0307692,0.53439,0.015625,{"medical_device_id":92,"generic_name":93,"class_classification":46,"jmdn_code":94,"name_similarity":95,"definition_similarity":37,"vector_similarity":96,"score":90},3741,"浣腸用チップ","11583000",0.108108,0.402492,{"medical_device_id":98,"generic_name":99,"class_classification":46,"jmdn_code":100,"name_similarity":101,"definition_similarity":37,"vector_similarity":102,"score":103},3536,"微生物由来成分分析装置","70183000",0.0714286,0.531939,0.0153846,{"medical_device_id":105,"generic_name":106,"class_classification":46,"jmdn_code":107,"name_similarity":108,"definition_similarity":37,"vector_similarity":109,"score":103},4396,"検眼レンズ","34653000",0.105263,0.399086,[111,115,119,123,126,129,132,135],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"LSR","Reagent, Borrelia Serological Reagent",112,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"LIP","Enzyme Linked Immunoabsorption Assay, Treponema Pallidum",35,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"JWL","Antigen, Treponema Pallidum For Fta-Abs Test",4,{"product_code":124,"device_name":125,"device_class":8,"k510_count":40},"GMS","Anti-Human Globulin, Fta-Abs Test",{"product_code":127,"device_name":128,"device_class":8,"k510_count":37},"GMR","Sera, Reactive And Non-Specific Control, Fta-Abs Test",{"product_code":130,"device_name":131,"device_class":8,"k510_count":37},"GMW","Test, Sorbent, Fta-Abs",{"product_code":133,"device_name":134,"device_class":8,"k510_count":37},"GMX","Antisera, Fluorescent Antibody For Fta-Abs Test",{"product_code":136,"device_name":137,"device_class":8,"k510_count":37},"MYR","Test, Donor, Syphilis, Antigens, Treponemal",{"510k":139,"classification":140,"enforcement":141,"event":142,"pma":143,"warning_letter":144},"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"]