[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-CHQ":3},{"classification":4,"mappedDevices":39,"similarCandidates":40,"relatedClassifications":111,"syncDates":116,"translation":123,"marketSummary":129,"recalls":143,"k510s":145,"pmas":185},{"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":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":38,"pma_count":36,"event_count":36},6860,"CHQ","Chromatographic\u002FFluorometric 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":32,"product_code":6,"review_panel":10,"gmp_exempt_flag":32,"third_party_flag":32,"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":33},{"k_number":17,"fei_number":28,"registration_number":31},[18,19,20,21,22,23,24,25,26,27],"K855214","K952919","K972167","K032199","K931148","K963938","K943099","K894966","K051969","K873371",[29,30],"2915274","3003951180",[29,30],"N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:48.882786+00:00",0,null,10,[],[41,49,56,63,71,78,85,92,98,105],{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":36,"vector_similarity":47,"score":48},3524,"カテコールアミン分析装置","Ⅰ","35989000",0.267857,0.79525,0.0327869,{"medical_device_id":50,"generic_name":51,"class_classification":44,"jmdn_code":52,"name_similarity":53,"definition_similarity":36,"vector_similarity":54,"score":55},3501,"蛍光式電解質分析装置","34555000",0.191176,0.644567,0.032002,{"medical_device_id":57,"generic_name":58,"class_classification":44,"jmdn_code":59,"name_similarity":60,"definition_similarity":36,"vector_similarity":61,"score":62},3518,"高速液体クロマトグラフィ分析装置","36420000",0.158537,0.646363,0.0304147,{"medical_device_id":64,"generic_name":65,"class_classification":66,"jmdn_code":67,"name_similarity":68,"definition_similarity":36,"vector_similarity":69,"score":70},1233,"据置型アナログ式循環器用X線透視診断装置","Ⅱ","37616000",0.131313,0.596466,0.0251662,{"medical_device_id":72,"generic_name":73,"class_classification":66,"jmdn_code":74,"name_similarity":75,"definition_similarity":36,"vector_similarity":76,"score":77},1232,"移動型アナログ式循環器用X線透視診断装置","37614000",0.147368,0.589346,0.0245693,{"medical_device_id":79,"generic_name":80,"class_classification":66,"jmdn_code":81,"name_similarity":82,"definition_similarity":36,"vector_similarity":83,"score":84},1924,"胆管造影用カテーテル","16429000",0.183333,0.552838,0.015873,{"medical_device_id":86,"generic_name":87,"class_classification":66,"jmdn_code":88,"name_similarity":89,"definition_similarity":36,"vector_similarity":90,"score":91},1386,"色素希釈心拍出量計","16177000",0.025974,0.634585,0.015625,{"medical_device_id":93,"generic_name":94,"class_classification":66,"jmdn_code":95,"name_similarity":96,"definition_similarity":36,"vector_similarity":97,"score":91},2000,"男性尿道造影向け泌尿器用カテーテル","32089000",0.180556,0.537024,{"medical_device_id":99,"generic_name":100,"class_classification":66,"jmdn_code":101,"name_similarity":102,"definition_similarity":36,"vector_similarity":103,"score":104},3117,"色素希釈心拍出量計用プログラム","16177012",0.043956,0.611864,0.0153846,{"medical_device_id":106,"generic_name":107,"class_classification":44,"jmdn_code":108,"name_similarity":109,"definition_similarity":36,"vector_similarity":110,"score":104},3319,"胸部X線間接撮影用防護箱","70042000",0.179487,0.531133,[112],{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"CHT","Electrophoretic Method, Catecholamines",2,{"510k":117,"classification":118,"enforcement":119,"event":120,"pma":121,"warning_letter":122},"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":124,"definition_ja":37,"commentary_ja":125,"model_name":126,"source_hash":127,"reviewed_by":37,"reviewed_at":37,"created_at":128,"updated_at":128},"カテコールアミン測定用クロマトグラフィー・蛍光測定装置","本品は、血液や尿などの検体中に含まれるカテコールアミンを、クロマトグラフィー法および蛍光測定法により定量するための臨床化学検査用機器です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされているため、市販前の個別審査を経ずに流通させることが可能です。","claude-sonnet-5","6971397f799e1b1292697bb81ccc62af4408ea48593830616665671e76327301","2026-08-24T01:44:46.715951+00:00",{"product_code":6,"summary_ja":130,"stats":131,"stats_hash":141,"model_name":126,"created_at":142,"updated_at":142},"本製品コードは、510(k)届出が累計10件、参入企業数は5社となっていますが、直近5年間の届出はなく、最新の判定は2005年10月です。PMAによる承認事例は確認されていません。不具合報告および回収について、いずれも累計件数は0件であり、確認されていません。",{"pma":132,"k510":133,"as_of":136,"events":137,"recalls":138,"top_problems":140},{"latest":37,"originals":36,"supplements":36},{"total":38,"last5y":36,"latest":134,"applicants":135},"2005-10-03",5,"2026-08",{"death":36,"other":36,"total":36,"injury":36,"last5y":36,"malfunction":36,"latest_month":37},{"total":36,"last5y":36,"latest":37,"class_i":36,"class_ii":36,"class_iii":36,"top_root_causes":139},[],[],"f1500a5f3333133db8846a708e05ce3f7b2a77a28a8bbd2eeb405ad526a52546","2026-08-24T04:10:52.385113+00:00",{"items":144,"total":36},[],{"items":146,"total":38},[147,153,158,162,165,168,171,174,178,181],{"k_number":26,"device_name":148,"applicant":149,"decision_date":134,"clearance_type":150,"decision_code":151,"statement_or_summary":152},"TRICAT RIA (ADRENALIN\u002FNORADRENALIN\u002FDOPAMINE); KATCOMBI RIA (ADRENALIN\u002FNORADRENALIN); NORADRENALIN RIA","Ibl GmbH","Traditional","SESE","Statement",{"k_number":21,"device_name":154,"applicant":155,"decision_date":156,"clearance_type":150,"decision_code":151,"statement_or_summary":157},"ESA PLASMA FREE METANEPHRINE ANALYSIS KIT","Esa, Inc.","2004-01-30","Summary",{"k_number":20,"device_name":159,"applicant":160,"decision_date":161,"clearance_type":150,"decision_code":151,"statement_or_summary":157},"PLASMA CATECHOLAMINE KIT","Bioanalytical Systems, Inc.","1997-08-04",{"k_number":23,"device_name":163,"applicant":155,"decision_date":164,"clearance_type":150,"decision_code":151,"statement_or_summary":152},"MODEL 5500 CEAS","1996-12-26",{"k_number":19,"device_name":166,"applicant":160,"decision_date":167,"clearance_type":150,"decision_code":151,"statement_or_summary":157},"URINARY METANEPHRINE KIT","1995-09-06",{"k_number":24,"device_name":169,"applicant":160,"decision_date":170,"clearance_type":150,"decision_code":151,"statement_or_summary":157},"URINARY CATECHOLAMINE KIT","1994-10-07",{"k_number":22,"device_name":172,"applicant":155,"decision_date":173,"clearance_type":150,"decision_code":151,"statement_or_summary":157},"MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM","1993-06-09",{"k_number":25,"device_name":175,"applicant":176,"decision_date":177,"clearance_type":150,"decision_code":151,"statement_or_summary":37},"PLASMA CATECHOLAMINES BY HPLC","Bio-Rad","1989-10-25",{"k_number":27,"device_name":179,"applicant":176,"decision_date":180,"clearance_type":150,"decision_code":151,"statement_or_summary":37},"URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC)","1988-01-05",{"k_number":18,"device_name":182,"applicant":183,"decision_date":184,"clearance_type":150,"decision_code":151,"statement_or_summary":37},"CAT-3 CATECHOLAMINE ASSAY KIT","Whale Scientific, Inc.","1986-03-14",{"items":186,"total":36},[]]