[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-CHT":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":105,"syncDates":110,"translation":117,"marketSummary":123,"recalls":136,"k510s":138,"pmas":150},{"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":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":28},5284,"CHT","Electrophoretic Method, Catecholamines","1","862.1165","CH","Clinical Chemistry","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":17,"fei_number":20,"registration_number":23},[18,19],"K760920","K913196",[21,22],"2381321","3010361165",[21,22],"N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:48.366308+00:00",0,null,2,[],[33,41,48,56,64,71,78,85,92,99],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":28,"vector_similarity":39,"score":40},3524,"カテコールアミン分析装置","Ⅰ","35989000",0.319149,0.772436,0.0327869,{"medical_device_id":42,"generic_name":43,"class_classification":36,"jmdn_code":44,"name_similarity":45,"definition_similarity":28,"vector_similarity":46,"score":47},3502,"蛋白分画電気泳動分析装置","31365000",0.169014,0.627495,0.0292869,{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":28,"vector_similarity":54,"score":55},52,"心臓用カテーテル型電極","Ⅳ","11434100",0.175439,0.604782,0.0281746,{"medical_device_id":57,"generic_name":58,"class_classification":59,"jmdn_code":60,"name_similarity":61,"definition_similarity":28,"vector_similarity":62,"score":63},1627,"電気味覚計","Ⅱ","70100000",0.166667,0.612841,0.0276515,{"medical_device_id":65,"generic_name":66,"class_classification":36,"jmdn_code":67,"name_similarity":68,"definition_similarity":28,"vector_similarity":69,"score":70},3360,"網膜電位用電極","11460000",0.2,0.592609,0.0266458,{"medical_device_id":72,"generic_name":73,"class_classification":51,"jmdn_code":74,"name_similarity":75,"definition_similarity":28,"vector_similarity":76,"score":77},53,"ヘパリン使用心臓用カテーテル型電極","11434200",0.157143,0.601241,0.0246246,{"medical_device_id":79,"generic_name":80,"class_classification":59,"jmdn_code":81,"name_similarity":82,"definition_similarity":28,"vector_similarity":83,"score":84},1425,"電気音響トランスデューサ","37336000",0.160714,0.594156,0.0238129,{"medical_device_id":86,"generic_name":87,"class_classification":59,"jmdn_code":88,"name_similarity":89,"definition_similarity":28,"vector_similarity":90,"score":91},2598,"電気式う蝕検出装置","33995030",0.215686,0.56227,0.016129,{"medical_device_id":93,"generic_name":94,"class_classification":59,"jmdn_code":95,"name_similarity":96,"definition_similarity":28,"vector_similarity":97,"score":98},1485,"網膜電位計","11482000",0.212766,0.5913,0.015873,{"medical_device_id":100,"generic_name":101,"class_classification":36,"jmdn_code":102,"name_similarity":103,"definition_similarity":28,"vector_similarity":104,"score":98},3344,"再使用可能な心電用電極","42489000",0.112903,0.622206,[106],{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"CHQ","Chromatographic\u002FFluorometric Method, Catecholamines",10,{"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":29,"commentary_ja":119,"model_name":120,"source_hash":121,"reviewed_by":29,"reviewed_at":29,"created_at":122,"updated_at":122},"電気泳動法カテコールアミン測定装置","本品は、電気泳動法を用いて血液や尿などの検体中のカテコールアミン濃度を測定するための医療機器です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分に該当し、比較的リスクが低い体外診断用機器として扱われています。","claude-sonnet-5","3f125d2a4d174d152ee6a57995468b5305e14fd990350dd9cfdee53c26d303ea","2026-08-24T01:44:46.715951+00:00",{"product_code":6,"summary_ja":124,"stats":125,"stats_hash":134,"model_name":120,"created_at":135,"updated_at":135},"本製品は510(k)届出が累計2件あり、2社が参入していますが、直近5年間の届出はなく、最新の判定は1991年9月となっています。PMAの承認実績は確認されていません。不具合報告および回収については、いずれも累計件数が0件であり、報告・実施の実績は確認されていません。",{"pma":126,"k510":127,"as_of":129,"events":130,"recalls":131,"top_problems":133},{"latest":29,"originals":28,"supplements":28},{"total":30,"last5y":28,"latest":128,"applicants":30},"1991-09-25","2026-08",{"death":28,"other":28,"total":28,"injury":28,"last5y":28,"malfunction":28,"latest_month":29},{"total":28,"last5y":28,"latest":29,"class_i":28,"class_ii":28,"class_iii":28,"top_root_causes":132},[],[],"a7a18a5d8d99dd5c3b759b2b1bf71d9b995886ab3cda68a046aec66baacdb5dc","2026-08-24T04:10:52.385113+00:00",{"items":137,"total":28},[],{"items":139,"total":30},[140,146],{"k_number":19,"device_name":141,"applicant":142,"decision_date":128,"clearance_type":143,"decision_code":144,"statement_or_summary":145},"KODAK EKTACHEM DT SLIDES (LIPASE)","Eastman Kodak Company","Traditional","SESE","Statement",{"k_number":18,"device_name":147,"applicant":148,"decision_date":149,"clearance_type":143,"decision_code":144,"statement_or_summary":29},"CAT-A-KIT","The Upjohn Co.","1976-11-09",{"items":151,"total":28},[]]