[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NWM":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":120,"syncDates":168},{"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":31,"updated_at":32,"recall_count":33,"latest_recall_date":34,"k510_count":35,"pma_count":33,"event_count":36},4499,"NWM","Immunoassay, Anti-Seizure Drug","2","862.3350","TX","Clinical Toxicology","1","To aid in management of patients treated with anti-seizure drug.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":27,"device_class":8,"implant_flag":28,"product_code":6,"review_panel":10,"gmp_exempt_flag":28,"third_party_flag":29,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":27,"life_sustain_support_flag":28,"medical_specialty_description":11,"summary_malfunction_reporting":30},{"k_number":17,"fei_number":23,"registration_number":26},[18,19,20,21,22],"K070645","K051211","K201089","K083799","K091884",[24,25],"3010939897","3005755244",[24,25],"","N","Y","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,2,[],[39,48,56,64,72,80,88,96,104,112],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47},3505,"酵素免疫測定装置","Ⅰ","35706010",0.318182,0.121693,0.680971,0.0320184,{"medical_device_id":49,"generic_name":50,"class_classification":42,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.28,0.075,0.694536,0.0317781,{"medical_device_id":57,"generic_name":58,"class_classification":42,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},3512,"免疫発光測定装置","36223010",0.259259,0.116592,0.693127,0.0310544,{"medical_device_id":65,"generic_name":66,"class_classification":42,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},3506,"移動式酵素免疫測定装置","35706020",0.27451,0.113514,0.677792,0.0310096,{"medical_device_id":73,"generic_name":74,"class_classification":42,"jmdn_code":75,"name_similarity":76,"definition_similarity":77,"vector_similarity":78,"score":79},3567,"イムノアッセイ用検体前処理装置","30870000",0.282609,0.1,0.65578,0.0308349,{"medical_device_id":81,"generic_name":82,"class_classification":42,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":87},3513,"移動式免疫発光測定装置","36223020",0.229508,0.114679,0.686072,0.0305789,{"medical_device_id":89,"generic_name":90,"class_classification":42,"jmdn_code":91,"name_similarity":92,"definition_similarity":93,"vector_similarity":94,"score":95},3555,"ラジオイムノアッセイ用装置","35506000",0.272727,0.100671,0.65815,0.0300769,{"medical_device_id":97,"generic_name":98,"class_classification":42,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},3514,"粒子計測免疫測定装置","70181000",0.277778,0.12,0.651394,0.0295716,{"medical_device_id":105,"generic_name":106,"class_classification":42,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},3510,"免疫蛍光分析装置","35707010",0.163265,0.157658,0.662211,0.029236,{"medical_device_id":113,"generic_name":114,"class_classification":42,"jmdn_code":115,"name_similarity":116,"definition_similarity":117,"vector_similarity":118,"score":119},3508,"免疫比濁分析装置","35926010",0.156863,0.104418,0.65354,0.0281914,[121,125,129,133,136,140,143,146,149,153,156,159,162,165],{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"DIP","Enzyme Immunoassay, Diphenylhydantoin",44,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"LGR","Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)",15,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"LES","Fluorescent Immunoassay, Diphenylhydantoin",7,{"product_code":134,"device_name":135,"device_class":8,"k510_count":35},"DLP","Radioimmunoassay, Diphenylhydantoin",{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"MOJ","Fluorescence Polarization Immunoassay, Diphenylhydantoin (Free)",3,{"product_code":141,"device_name":142,"device_class":8,"k510_count":36},"DKH","Gas Chromatography, Diphenylhydantoin",{"product_code":144,"device_name":145,"device_class":8,"k510_count":36},"ORH","Lamotrigine Assay",{"product_code":147,"device_name":148,"device_class":8,"k510_count":36},"ORI","Levetiracetam Assay",{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"DOZ","Liquid Chromatography, Diphenylhydantoin",1,{"product_code":154,"device_name":155,"device_class":8,"k510_count":152},"DPE","Thin Layer Chromatography, Diphenylhydantoin",{"product_code":157,"device_name":158,"device_class":8,"k510_count":152},"LFO","Nephelometric Inhibition Immunoassay, Diphenylhydantoin",{"product_code":160,"device_name":161,"device_class":8,"k510_count":152},"MSL","System, Test, Topiramatee",{"product_code":163,"device_name":164,"device_class":8,"k510_count":152},"OTF","Gabapentin Assay",{"product_code":166,"device_name":167,"device_class":8,"k510_count":33},"LDC","U.V. Spectrometry, Diphenylhydantoin",{"510k":169,"classification":170,"enforcement":171,"event":172,"pma":173,"warning_letter":174},"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","2026-08-18T06:42:29.411+00:00"]