[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LKZ":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":102,"syncDates":107,"translation":114,"marketSummary":120,"recalls":133,"k510s":135,"pmas":146},{"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":23,"updated_at":24,"recall_count":25,"latest_recall_date":26,"k510_count":27,"pma_count":25,"event_count":25},2425,"LKZ","Red-Cell Count By Photometry","2","864.7100","HE","Hematology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":10,"gmp_exempt_flag":20,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"k_number":17},[18,19],"K833708","K832771","N","Y","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:47.808424+00:00",0,null,2,[],[30,38,45,52,59,66,73,81,88,94],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":25,"vector_similarity":36,"score":37},3537,"血球計数装置","Ⅰ","35476000",0.261905,0.718067,0.0327869,{"medical_device_id":39,"generic_name":40,"class_classification":33,"jmdn_code":41,"name_similarity":42,"definition_similarity":25,"vector_similarity":43,"score":44},3539,"手動式血球計数装置","35103000",0.20339,0.692099,0.032002,{"medical_device_id":46,"generic_name":47,"class_classification":33,"jmdn_code":48,"name_similarity":49,"definition_similarity":25,"vector_similarity":50,"score":51},3548,"セルアナライザ","70184000",0.135135,0.647713,0.0272222,{"medical_device_id":53,"generic_name":54,"class_classification":33,"jmdn_code":55,"name_similarity":56,"definition_similarity":25,"vector_similarity":57,"score":58},3522,"ビリルビン分析装置","35475000",0.12766,0.667543,0.0264808,{"medical_device_id":60,"generic_name":61,"class_classification":33,"jmdn_code":62,"name_similarity":63,"definition_similarity":25,"vector_similarity":64,"score":65},3527,"ポータブル臨床用屈折計","37034000",0.132075,0.633257,0.024269,{"medical_device_id":67,"generic_name":68,"class_classification":33,"jmdn_code":69,"name_similarity":70,"definition_similarity":25,"vector_similarity":71,"score":72},3533,"体外検査用オキシメータ","15201000",0.0222222,0.697782,0.016129,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":25,"vector_similarity":79,"score":80},762,"血球細胞除去用装置","Ⅲ","70542000",0.181818,0.611993,0.015873,{"medical_device_id":82,"generic_name":83,"class_classification":33,"jmdn_code":84,"name_similarity":85,"definition_similarity":25,"vector_similarity":86,"score":87},3408,"眼位計","17119000",0.147059,0.62754,0.015625,{"medical_device_id":89,"generic_name":90,"class_classification":33,"jmdn_code":91,"name_similarity":92,"definition_similarity":25,"vector_similarity":93,"score":87},3514,"粒子計測免疫測定装置","70181000",0.0983607,0.686288,{"medical_device_id":95,"generic_name":96,"class_classification":97,"jmdn_code":98,"name_similarity":99,"definition_similarity":25,"vector_similarity":100,"score":101},1530,"テレメトリー式心拍陣痛計受信機","Ⅱ","38480000",0.145455,0.528719,0.0153846,[103],{"product_code":104,"device_name":105,"device_class":8,"k510_count":106},"JBE","Cell Enzymes (Erythrocytic And Leukocytic)",1,{"510k":108,"classification":109,"enforcement":110,"event":111,"pma":112,"warning_letter":113},"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":115,"definition_ja":26,"commentary_ja":116,"model_name":117,"source_hash":118,"reviewed_by":26,"reviewed_at":26,"created_at":119,"updated_at":119},"光電比色法赤血球計数装置","本機器は米国FDAの規制区分においてクラスIIに分類されており、市販前届出（510(k)）による審査が求められます。クラスIIは中程度のリスクを有する医療機器を対象とし、一般的な管理に加え、性能規格などの特別管理が必要とされる区分です。","claude-sonnet-5","bb12d4b5ebc18e89d3da11eddb888b6737929954115fd94c729098901b653a54","2026-08-24T02:11:36.699753+00:00",{"product_code":6,"summary_ja":121,"stats":122,"stats_hash":131,"model_name":117,"created_at":132,"updated_at":132},"510(k)の累計件数は2件で、参入企業数は2社ですが、直近5年間の届出実績は確認されていません。最新の判定は1984年1月となっています。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・実績は確認されていません。",{"pma":123,"k510":124,"as_of":126,"events":127,"recalls":128,"top_problems":130},{"latest":26,"originals":25,"supplements":25},{"total":27,"last5y":25,"latest":125,"applicants":27},"1984-01-04","2026-08",{"death":25,"other":25,"total":25,"injury":25,"last5y":25,"malfunction":25,"latest_month":26},{"total":25,"last5y":25,"latest":26,"class_i":25,"class_ii":25,"class_iii":25,"top_root_causes":129},[],[],"450a1a88207f5c59021f17eaf0df6751b6010fae68ca577113fc79906e2cf8b2","2026-08-24T04:50:56.354429+00:00",{"items":134,"total":25},[],{"items":136,"total":27},[137,142],{"k_number":18,"device_name":138,"applicant":139,"decision_date":125,"clearance_type":140,"decision_code":141,"statement_or_summary":26},"COMPUR* M1000 HEMOGLOBIN & ERYTHROCYTE","Worthington Diagnostic Systems","Traditional","SESE",{"k_number":19,"device_name":143,"applicant":144,"decision_date":145,"clearance_type":140,"decision_code":141,"statement_or_summary":26},"ERYTHROCYTE TEST","Bio-Analytics Laboratories, Inc.","1983-10-28",{"items":147,"total":25},[]]