[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LDN":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":103,"syncDates":115,"translation":122,"marketSummary":128,"recalls":142,"k510s":144,"pmas":158},{"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":24,"updated_at":25,"recall_count":26,"latest_recall_date":27,"k510_count":28,"pma_count":26,"event_count":26},1592,"LDN","Enzymatic Radiochemical Assay, Amikacin","2","862.3035","TX","Clinical Toxicology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":21,"product_code":6,"review_panel":10,"gmp_exempt_flag":21,"third_party_flag":22,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":21,"medical_specialty_description":11,"summary_malfunction_reporting":23},{"k_number":17},[18,19,20],"K840647","K833546","K820440","N","Y","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-24T02:00:49.169481+00:00",0,null,3,[],[31,39,46,53,61,68,76,83,89,96],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":26,"vector_similarity":37,"score":38},3555,"ラジオイムノアッセイ用装置","Ⅰ","35506000",0.185185,0.642113,0.0327869,{"medical_device_id":40,"generic_name":41,"class_classification":34,"jmdn_code":42,"name_similarity":43,"definition_similarity":26,"vector_similarity":44,"score":45},3506,"移動式酵素免疫測定装置","35706020",0.15873,0.586887,0.0287829,{"medical_device_id":47,"generic_name":48,"class_classification":34,"jmdn_code":49,"name_similarity":50,"definition_similarity":26,"vector_similarity":51,"score":52},3505,"酵素免疫測定装置","35706010",0.178571,0.581697,0.0284747,{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":26,"vector_similarity":59,"score":60},1283,"RI動態機能検査装置","Ⅱ","70008000",0.118421,0.600473,0.0276506,{"medical_device_id":62,"generic_name":63,"class_classification":34,"jmdn_code":64,"name_similarity":65,"definition_similarity":26,"vector_similarity":66,"score":67},3535,"酵素分析装置","35470000",0.125,0.579901,0.0259371,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":26,"vector_similarity":74,"score":75},327,"骨放射線吸収測定装置用放射線源","Ⅲ","38315000",0.0833333,0.620795,0.016129,{"medical_device_id":77,"generic_name":78,"class_classification":71,"jmdn_code":79,"name_similarity":80,"definition_similarity":26,"vector_similarity":81,"score":82},849,"定位放射線手術向け治療用放射線源","38306000",0.0823529,0.616979,0.015873,{"medical_device_id":84,"generic_name":85,"class_classification":34,"jmdn_code":86,"name_similarity":87,"definition_similarity":26,"vector_similarity":88,"score":82},3272,"自動シネフィルムX線フィルム現像装置","41014000",0.15942,0.531525,{"medical_device_id":90,"generic_name":91,"class_classification":56,"jmdn_code":92,"name_similarity":93,"definition_similarity":26,"vector_similarity":94,"score":95},1282,"骨放射線吸収測定装置","38314000",0.0987654,0.616867,0.015625,{"medical_device_id":97,"generic_name":98,"class_classification":56,"jmdn_code":99,"name_similarity":100,"definition_similarity":26,"vector_similarity":101,"score":102},1286,"甲状腺摂取率測定用核医学装置","40648000",0.0116279,0.612663,0.0153846,[104,108,112],{"product_code":105,"device_name":106,"device_class":8,"k510_count":107},"KLQ","Radioimmunoassay, Amikacin",20,{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"KLP","Amikacin Serum Assay",4,{"product_code":113,"device_name":114,"device_class":8,"k510_count":28},"LGJ","Fluorescence Polarization Immunoassay, Amibacin",{"510k":116,"classification":117,"enforcement":118,"event":119,"pma":120,"warning_letter":121},"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":123,"definition_ja":27,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":27,"reviewed_at":27,"created_at":127,"updated_at":127},"アミカシン酵素放射化学分析装置","本品は、血液等の検体中に含まれる抗生物質アミカシンの濃度を、酵素反応と放射化学的手法を組み合わせて測定するための体外診断用機器です。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て、既存の同等品との実質的同等性が確認されることで市販が認められます。","claude-sonnet-5","4b57de19c797516cda2a03e7d8f8134d50c2185c5439e9c5c26644b9a0a93279","2026-08-24T02:10:16.590298+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":140,"model_name":125,"created_at":141,"updated_at":141},"本製品コードの510(k)届出は累計3件で、参入企業数は2社となっています。直近5年間の届出、PMA承認、不具合報告、回収のいずれについても件数は確認されていません。最新の510(k)判定は1984年4月です。",{"pma":131,"k510":132,"as_of":135,"events":136,"recalls":137,"top_problems":139},{"latest":27,"originals":26,"supplements":26},{"total":28,"last5y":26,"latest":133,"applicants":134},"1984-04-02",2,"2026-08",{"death":26,"other":26,"total":26,"injury":26,"last5y":26,"malfunction":26,"latest_month":27},{"total":26,"last5y":26,"latest":27,"class_i":26,"class_ii":26,"class_iii":26,"top_root_causes":138},[],[],"32e602e57146b87f940f6f9220d6778df3a0c91e3c036b7bb72d0e63298e6e0b","2026-08-24T04:49:04.081036+00:00",{"items":143,"total":26},[],{"items":145,"total":28},[146,151,155],{"k_number":18,"device_name":147,"applicant":148,"decision_date":133,"clearance_type":149,"decision_code":150,"statement_or_summary":27},"AMIKACIN REAGENT TEST KIT","Beckman Instruments, Inc.","Traditional","SESE",{"k_number":19,"device_name":152,"applicant":153,"decision_date":154,"clearance_type":149,"decision_code":150,"statement_or_summary":27},"MODIFICATION OF EMIT AND AMIKACIN ASSAY","Syva Co.","1983-12-08",{"k_number":20,"device_name":156,"applicant":153,"decision_date":157,"clearance_type":149,"decision_code":150,"statement_or_summary":27},"EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO","1982-03-15",{"items":159,"total":26},[]]