[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GMK":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":110,"syncDates":126},{"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":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":37,"pma_count":35,"event_count":35},3580,"GMK","Antiserum, Positive Control, Histoplasma Capsulatum","2","866.3320","MI","Microbiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"k_number":17,"fei_number":27,"registration_number":30},[18,19,20,21,22,23,24,25,26],"K792692","K760832","K792679","K792718","K791392","K791390","K792694","K791395","K760831",[28,29],"1524213","1627497",[28,29],"N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-18T22:05:38.961415+00:00",0,null,9,[],[40,48,56,63,71,78,84,91,97,104],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":35,"vector_similarity":46,"score":47},748,"選択式血漿成分吸着器","Ⅲ","70533000",0.166667,0.546761,0.0265152,{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":35,"vector_similarity":54,"score":55},3277,"X線自動露出制御器","Ⅰ","34311000",0.140845,0.548181,0.0258333,{"medical_device_id":57,"generic_name":58,"class_classification":43,"jmdn_code":59,"name_similarity":60,"definition_similarity":35,"vector_similarity":61,"score":62},957,"再使用可能なハンドコントロール式電気手術器用アクティブ電極","42552000",0.131868,0.547964,0.0248457,{"medical_device_id":64,"generic_name":65,"class_classification":66,"jmdn_code":67,"name_similarity":68,"definition_similarity":35,"vector_similarity":69,"score":70},2986,"男性向け避妊用コンドーム","Ⅱ","36282000",0.126984,0.546797,0.0228579,{"medical_device_id":72,"generic_name":73,"class_classification":66,"jmdn_code":74,"name_similarity":75,"definition_similarity":35,"vector_similarity":76,"score":77},2436,"イオン浸透式鼓膜麻酔器","70575000",0.0531915,0.582014,0.0163934,{"medical_device_id":79,"generic_name":80,"class_classification":66,"jmdn_code":81,"name_similarity":82,"definition_similarity":35,"vector_similarity":83,"score":77},2438,"持続的気道陽圧法酸素供給用経鼻カニューレ","35202000",0.21519,0.520596,{"medical_device_id":85,"generic_name":86,"class_classification":43,"jmdn_code":87,"name_similarity":88,"definition_similarity":35,"vector_similarity":89,"score":90},783,"持続的気道陽圧ユニット","36700000",0.205479,0.490663,0.016129,{"medical_device_id":92,"generic_name":93,"class_classification":51,"jmdn_code":94,"name_similarity":95,"definition_similarity":35,"vector_similarity":96,"score":90},3316,"放射線防護用帽子","70041000",0.0606061,0.563157,{"medical_device_id":98,"generic_name":99,"class_classification":43,"jmdn_code":100,"name_similarity":101,"definition_similarity":35,"vector_similarity":102,"score":103},787,"持続的自動気道陽圧ユニット","37234000",0.182927,0.47615,0.015873,{"medical_device_id":105,"generic_name":106,"class_classification":51,"jmdn_code":107,"name_similarity":108,"definition_similarity":35,"vector_similarity":109,"score":103},3304,"放射線防護用手袋","38364000",0.0138889,0.563037,[111,115,119,123],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"GMJ","Antigens, Histoplasma Capsulatum, All",12,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"MIZ","Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum",2,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"MBT","Dna-Probe, Reagent, Histoplasma Capsulatum",1,{"product_code":124,"device_name":125,"device_class":8,"k510_count":35},"GML","Antisera, Fluorescent, Histoplasma Capsulatum",{"510k":127,"classification":128,"enforcement":129,"event":130,"pma":131,"warning_letter":132},"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"]