[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GTC":3},{"classification":4,"mappedDevices":26,"similarCandidates":27,"relatedClassifications":95,"syncDates":99,"translation":106,"marketSummary":112,"recalls":125,"k510s":127,"pmas":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},6231,"GTC","Antisera, All Types, Klebsiella Spp.","1","866.3340","MI","Microbiology","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],"K830276","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-24T02:00:48.758894+00:00",0,null,1,[],[28,36,43,51,56,64,69,76,82,89],{"medical_device_id":29,"generic_name":30,"class_classification":31,"jmdn_code":32,"name_similarity":33,"definition_similarity":23,"vector_similarity":34,"score":35},3580,"微生物感受性分析装置","Ⅰ","34574000",0.103448,0.546067,0.0285773,{"medical_device_id":37,"generic_name":38,"class_classification":31,"jmdn_code":39,"name_similarity":40,"definition_similarity":23,"vector_similarity":41,"score":42},4446,"微生物定量分析装置","71086001",0.0833333,0.526613,0.0242504,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":23,"vector_similarity":49,"score":50},2665,"歯科鋳造用銀合金第1種","Ⅱ","70777000",0.133333,0.439077,0.0163934,{"medical_device_id":52,"generic_name":53,"class_classification":31,"jmdn_code":54,"name_similarity":23,"definition_similarity":23,"vector_similarity":55,"score":50},3581,"微生物培養装置","70189000",0.579806,{"medical_device_id":57,"generic_name":58,"class_classification":59,"jmdn_code":60,"name_similarity":61,"definition_similarity":23,"vector_similarity":62,"score":63},503,"抗菌性創傷被覆・保護材","Ⅲ","34614000",0.0769231,0.579428,0.016129,{"medical_device_id":65,"generic_name":66,"class_classification":46,"jmdn_code":67,"name_similarity":48,"definition_similarity":23,"vector_similarity":68,"score":63},2666,"歯科鋳造用銀合金第2種","70778000",0.443638,{"medical_device_id":70,"generic_name":71,"class_classification":59,"jmdn_code":72,"name_similarity":73,"definition_similarity":23,"vector_similarity":74,"score":75},433,"抗菌作用緊急時ブラッドアクセス留置用カテーテル","70320200",0.060241,0.568089,0.015873,{"medical_device_id":77,"generic_name":78,"class_classification":31,"jmdn_code":79,"name_similarity":80,"definition_similarity":23,"vector_similarity":81,"score":75},3548,"セルアナライザ","70184000",0.119048,0.447421,{"medical_device_id":83,"generic_name":84,"class_classification":59,"jmdn_code":85,"name_similarity":86,"definition_similarity":23,"vector_similarity":87,"score":88},615,"全人工足関節","32837000",0.115385,0.414638,0.015625,{"medical_device_id":90,"generic_name":91,"class_classification":31,"jmdn_code":92,"name_similarity":93,"definition_similarity":23,"vector_similarity":94,"score":88},3536,"微生物由来成分分析装置","70183000",0.0508475,0.564747,[96],{"product_code":97,"device_name":98,"device_class":8,"k510_count":23},"GTB","Antisera, Fluorescent, All Types, Klebsiella Spp.",{"510k":100,"classification":101,"enforcement":102,"event":103,"pma":104,"warning_letter":105},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":107,"definition_ja":24,"commentary_ja":108,"model_name":109,"source_hash":110,"reviewed_by":24,"reviewed_at":24,"created_at":111,"updated_at":111},"クレブシエラ属抗血清","本品は米国FDAの規制上クラスIに分類される体外診断用医療機器であり、市販前届出（510(k)）が免除されています。クラスIは一般に安全性・有効性のリスクが低い機器に適用される区分であり、多くの場合510(k)による市販前届出も不要とされています。","claude-sonnet-5","1ac3791858ff4f33c71543a415c8ad24a620e62b7e6c8a3d5e135a02cc6c5dd8","2026-08-24T01:55:21.85667+00:00",{"product_code":6,"summary_ja":113,"stats":114,"stats_hash":123,"model_name":109,"created_at":124,"updated_at":124},"本製品コードは届出免除区分であり、510(k)は累計1件の届出が確認されていますが、直近5年間の届出はありません。不具合報告および回収については、いずれも累計0件であり、確認されていません。",{"pma":115,"k510":116,"as_of":118,"events":119,"recalls":120,"top_problems":122},{"latest":24,"originals":23,"supplements":23},{"total":25,"last5y":23,"latest":117,"applicants":25},"1983-03-29","2026-08",{"death":23,"other":23,"total":23,"injury":23,"last5y":23,"malfunction":23,"latest_month":24},{"total":23,"last5y":23,"latest":24,"class_i":23,"class_ii":23,"class_iii":23,"top_root_causes":121},[],[],"3fdd906d6ffc4f1ae39f82480b1519b4b669099728f54208873b15707742d311","2026-08-24T04:30:57.116764+00:00",{"items":126,"total":23},[],{"items":128,"total":25},[129],{"k_number":18,"device_name":130,"applicant":131,"decision_date":117,"clearance_type":132,"decision_code":133,"statement_or_summary":24},"SECURET DRAPE & INSTRUMENT RETAINER\u002FINCL","Ritmed, Inc.","Traditional","SESE",{"items":135,"total":23},[]]