[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KLO":3},{"classification":4,"mappedDevices":23,"similarCandidates":24,"relatedClassifications":94,"syncDates":124},{"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":20,"updated_at":20,"recall_count":21,"latest_recall_date":22,"k510_count":21,"pma_count":21,"event_count":21},2324,"KLO","Enzymatic Radiochemical Assay, Gentamicin","2","862.3450","TX","Clinical Toxicology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":17,"product_code":6,"review_panel":10,"gmp_exempt_flag":17,"third_party_flag":18,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":17,"medical_specialty_description":11,"summary_malfunction_reporting":19},{},"N","Y","Eligible","2026-08-18T05:52:49.993647+00:00",0,null,[],[25,33,40,48,55,61,68,74,81,87],{"medical_device_id":26,"generic_name":27,"class_classification":28,"jmdn_code":29,"name_similarity":30,"definition_similarity":21,"vector_similarity":31,"score":32},3555,"ラジオイムノアッセイ用装置","Ⅰ","35506000",0.178571,0.639665,0.0327869,{"medical_device_id":34,"generic_name":35,"class_classification":28,"jmdn_code":36,"name_similarity":37,"definition_similarity":21,"vector_similarity":38,"score":39},3506,"移動式酵素免疫測定装置","35706020",0.153846,0.582977,0.0277303,{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":21,"vector_similarity":46,"score":47},1283,"RI動態機能検査装置","Ⅱ","70008000",0.12987,0.595347,0.0259893,{"medical_device_id":49,"generic_name":50,"class_classification":43,"jmdn_code":51,"name_similarity":52,"definition_similarity":21,"vector_similarity":53,"score":54},1286,"甲状腺摂取率測定用核医学装置","40648000",0.0348837,0.635164,0.016129,{"medical_device_id":56,"generic_name":57,"class_classification":28,"jmdn_code":58,"name_similarity":59,"definition_similarity":21,"vector_similarity":60,"score":54},3505,"酵素免疫測定装置","35706010",0.172414,0.572669,{"medical_device_id":62,"generic_name":63,"class_classification":43,"jmdn_code":64,"name_similarity":65,"definition_similarity":21,"vector_similarity":66,"score":67},1282,"骨放射線吸収測定装置","38314000",0.0963855,0.614744,0.015873,{"medical_device_id":69,"generic_name":70,"class_classification":28,"jmdn_code":71,"name_similarity":72,"definition_similarity":21,"vector_similarity":73,"score":67},4029,"歯科用根管ラスプ","41878000",0.166667,0.437307,{"medical_device_id":75,"generic_name":76,"class_classification":28,"jmdn_code":77,"name_similarity":78,"definition_similarity":21,"vector_similarity":79,"score":80},3272,"自動シネフィルムX線フィルム現像装置","41014000",0.15493,0.528381,0.015625,{"medical_device_id":82,"generic_name":83,"class_classification":28,"jmdn_code":84,"name_similarity":85,"definition_similarity":21,"vector_similarity":86,"score":80},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.0882353,0.612164,{"medical_device_id":88,"generic_name":89,"class_classification":43,"jmdn_code":90,"name_similarity":91,"definition_similarity":21,"vector_similarity":92,"score":93},1284,"核医学診断用直線型スキャナ","40645000",0.038961,0.606121,0.0153846,[95,99,103,106,110,114,118,121],{"product_code":96,"device_name":97,"device_class":8,"k510_count":98},"LCD","Enzyme Immunoassay, Gentamicin",37,{"product_code":100,"device_name":101,"device_class":8,"k510_count":102},"DJB","Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.",19,{"product_code":104,"device_name":105,"device_class":8,"k510_count":102},"LCQ","Fluorescent Immunoassay Gentamicin",{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"LCE","Radioimmunoassay, Netilmicin (I-125)",6,{"product_code":111,"device_name":112,"device_class":8,"k510_count":113},"DKD","Bacillus Subtilis, Microbiological Assay, Gentamicin",2,{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"DJI","Antiserum, Gentamicin",1,{"product_code":119,"device_name":120,"device_class":8,"k510_count":117},"DNO","Hemagglutination Inhibition, Gentamicin",{"product_code":122,"device_name":123,"device_class":8,"k510_count":117},"KZT","Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Gentamicin",{"510k":125,"classification":126,"enforcement":127,"event":128,"pma":129,"warning_letter":130},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]