[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MIG":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":109,"syncDates":110,"translation":117,"marketSummary":123,"recalls":137,"k510s":139,"pmas":152},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":9,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":32,"updated_at":33,"recall_count":34,"latest_recall_date":35,"k510_count":36,"pma_count":34,"event_count":37},2865,"MIG","Strip, Test Isoniazid","U","","Unknown","TX","7",false,{"openfda":15,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":29,"product_code":6,"review_panel":11,"gmp_exempt_flag":29,"third_party_flag":29,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":30,"life_sustain_support_flag":29,"medical_specialty_description":10,"summary_malfunction_reporting":31},{"k_number":16,"fei_number":19,"registration_number":26},[17,18],"K962615","K912888",[20,21,22,23,24,25],"3009077524","1000306431","1000114185","3009656988","3034694973","3000126629",[20,27,28,23,24,25],"2029275","1054811","N","1","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:49.029844+00:00",0,null,2,3,[],[40,48,56,63,69,76,83,90,96,102],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":34,"vector_similarity":46,"score":47},2159,"血液比重検査キット","Ⅱ","70363000",0.146341,0.569974,0.0303658,{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":34,"vector_similarity":54,"score":55},3596,"再使用可能な尖叉試験用針","Ⅰ","15679001",0.125,0.576127,0.0302823,{"medical_device_id":57,"generic_name":58,"class_classification":51,"jmdn_code":59,"name_similarity":60,"definition_similarity":34,"vector_similarity":61,"score":62},3495,"汗試験用イオン導入装置","15128000",0.179487,0.550815,0.0295716,{"medical_device_id":64,"generic_name":65,"class_classification":43,"jmdn_code":66,"name_similarity":45,"definition_similarity":34,"vector_similarity":67,"score":68},1819,"単回使用尖叉試験用針","15679012",0.545858,0.0280392,{"medical_device_id":70,"generic_name":71,"class_classification":43,"jmdn_code":72,"name_similarity":73,"definition_similarity":34,"vector_similarity":74,"score":75},2752,"歯科用色調適合確認材料","70845000",0.12,0.553138,0.0277992,{"medical_device_id":77,"generic_name":78,"class_classification":43,"jmdn_code":79,"name_similarity":80,"definition_similarity":34,"vector_similarity":81,"score":82},1820,"尖叉試験・ワクチン用針","15679022",0.131579,0.543392,0.0271062,{"medical_device_id":84,"generic_name":85,"class_classification":43,"jmdn_code":86,"name_similarity":87,"definition_similarity":34,"vector_similarity":88,"score":89},1448,"運動負荷試験用コンピュータ","35447000",0.186047,0.443202,0.0163934,{"medical_device_id":91,"generic_name":92,"class_classification":51,"jmdn_code":93,"name_similarity":34,"definition_similarity":34,"vector_similarity":94,"score":95},3534,"ヘパリン分析装置","33321000",0.575683,0.016129,{"medical_device_id":97,"generic_name":98,"class_classification":51,"jmdn_code":99,"name_similarity":100,"definition_similarity":34,"vector_similarity":101,"score":95},4292,"腱手術用ストリッパ","35380000",0.184211,0.479417,{"medical_device_id":103,"generic_name":104,"class_classification":51,"jmdn_code":105,"name_similarity":106,"definition_similarity":34,"vector_similarity":107,"score":108},3361,"汗試験用電極","11461000",0.166667,0.508563,0.015625,[],{"510k":111,"classification":112,"enforcement":113,"event":114,"pma":115,"warning_letter":116},"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":118,"definition_ja":35,"commentary_ja":119,"model_name":120,"source_hash":121,"reviewed_by":35,"reviewed_at":35,"created_at":122,"updated_at":122},"イソニアジド検査用試験紙","本品はイソニアジドの検査に用いる試験紙です。米国ではデバイスクラスが未分類（Unclassified）とされており、審査区分も市販前届出（510(k)）や市販前承認（PMA）ではなく、FDAが規制執行上の裁量により個別の審査を求めない「取締裁量（Enforcement Discretion）」の扱いとなっています。","claude-sonnet-5","7f4c175dd037d6460e5ba94bfb10d95abaafb8c673a112cd130ea730608c6224","2026-08-24T02:13:33.96397+00:00",{"product_code":6,"summary_ja":124,"stats":125,"stats_hash":135,"model_name":120,"created_at":136,"updated_at":136},"510(k)は累計2件で、参入企業数も2社となっており、最新の判定は1998年3月にとどまり、直近5年間の届出は確認されていません。不具合報告は累計3件で、いずれもMalfunction（不具合）であり、死亡・傷害の報告は確認されていません。回収については累計0件であり、クラスI〜IIIのいずれも確認されていません。",{"pma":126,"k510":127,"as_of":129,"events":130,"recalls":132,"top_problems":134},{"latest":35,"originals":34,"supplements":34},{"total":36,"last5y":34,"latest":128,"applicants":36},"1998-03-19","2026-08",{"death":34,"other":34,"total":37,"injury":34,"last5y":34,"malfunction":37,"latest_month":131},"2017-04",{"total":34,"last5y":34,"latest":35,"class_i":34,"class_ii":34,"class_iii":34,"top_root_causes":133},[],[],"ec17c0bbc02fb1f01f762c2aeda3907ea766e5ff22b0f3786464ebc0bc577b80","2026-08-24T04:54:58.317174+00:00",{"items":138,"total":34},[],{"items":140,"total":36},[141,147],{"k_number":17,"device_name":142,"applicant":143,"decision_date":128,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"TUMORLOCALIZER MRI","Ferguson Medical","Traditional","SESE","Summary",{"k_number":18,"device_name":148,"applicant":149,"decision_date":150,"clearance_type":144,"decision_code":145,"statement_or_summary":151},"URITEC TEST STRIP & HUMAN URINE + & - TEST CONTROL","Dynagen, Inc.","1992-02-24","Statement",{"items":153,"total":34},[]]