[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PVH":3},{"classification":4,"mappedDevices":62,"similarCandidates":63,"relatedClassifications":144,"syncDates":169},{"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":57,"updated_at":58,"recall_count":59,"latest_recall_date":60,"k510_count":59,"pma_count":59,"event_count":61},6181,"PVH","Test, Opiates, Employment And Insurance Testing, Exempt","2","862.3650","TX","Clinical Toxicology","4","The opiates test is an in vitro diagnostic test for the qualitative analysis of opiates for employment and insurance testing.    FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https:\u002F\u002Fwww.federalregister.gov\u002Fdocuments\u002F2017\u002F07\u002F11\u002F2017-14453\u002Fmedical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976).  Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register  (82 FR 31976) available at https:\u002F\u002Fwww.federalregister.gov\u002Fdocuments\u002F2017\u002F07\u002F11\u002F2017-14453\u002Fmedical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce.  If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":18,"device_class":8,"implant_flag":55,"product_code":6,"review_panel":10,"gmp_exempt_flag":55,"third_party_flag":55,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":18,"life_sustain_support_flag":55,"medical_specialty_description":11,"summary_malfunction_reporting":56},{"fei_number":17,"registration_number":51},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50],"","3030648160","3001451797","3043127647","3012073813","3014171027","3009238284","3032147516","3003102569","3004847291","3005755244","3008517993","3021010433","3023322455","3004635103","3027693054","3008852306","3006048451","3021986677","3018117195","3017060097","3011522054","3007606081","3003917514","3008825965","3003789989","3009585529","3005345870","3017904598","2020952","3010934853","3010800486","3027519599",[18,19,21,22,23,24,25,27,28,29,30,31,32,33,34,35,36,52,37,38,53,39,40,41,42,44,45,46,54,47,48,49,50],"2087033","1649661","2032598","N","Ineligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,[],[64,73,82,90,98,106,114,121,129,136],{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},3745,"医薬品注入器検査装置","Ⅰ","36794000",0.21875,0.139048,0.609635,0.0327869,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},1635,"十字靭帯機能検査機器","Ⅱ","70102000",0.189189,0.0623701,0.577492,0.0292111,{"medical_device_id":83,"generic_name":84,"class_classification":76,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},1377,"血圧脈波検査装置","70045000",0.185714,0.165584,0.569975,0.027972,{"medical_device_id":91,"generic_name":92,"class_classification":76,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},1593,"呼吸循環検査装置","70088000",0.157895,0.121331,0.579104,0.0278638,{"medical_device_id":99,"generic_name":100,"class_classification":67,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},3515,"便潜血測定装置","70182000",0.142857,0.115312,0.581419,0.0273897,{"medical_device_id":107,"generic_name":108,"class_classification":76,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},1613,"耳管機能検査装置","70097000",0.202703,0.187285,0.534597,0.016129,{"medical_device_id":115,"generic_name":116,"class_classification":76,"jmdn_code":117,"name_similarity":118,"definition_similarity":119,"vector_similarity":120,"score":113},1634,"定量的感覚検査用パルポメータ","40817000",0.0641026,0.158363,0.601644,{"medical_device_id":122,"generic_name":123,"class_classification":76,"jmdn_code":124,"name_similarity":125,"definition_similarity":126,"vector_similarity":127,"score":128},1376,"眼底血圧計","33384000",0.0149254,0.193388,0.583182,0.015873,{"medical_device_id":130,"generic_name":131,"class_classification":76,"jmdn_code":132,"name_similarity":133,"definition_similarity":134,"vector_similarity":135,"score":128},1598,"眼球運動検査装置","70093000",0.196721,0.126177,0.503559,{"medical_device_id":137,"generic_name":138,"class_classification":67,"jmdn_code":139,"name_similarity":140,"definition_similarity":141,"vector_similarity":142,"score":143},4339,"靭帯・腱手術用器械","70966001",0.19403,0.127789,0.420585,0.015625,[145,149,153,157,160,163,166],{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"DJG","Enzyme Immunoassay, Opiates",215,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"NGL","Test, Opiates, Over The Counter",23,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"DLT","Hemagglutination, Opiates",1,{"product_code":158,"device_name":159,"device_class":8,"k510_count":156},"LAI","Thin Layer Chromatography, Opiates",{"product_code":161,"device_name":162,"device_class":8,"k510_count":59},"DJF","Gas Chromatography, Opiates",{"product_code":164,"device_name":165,"device_class":8,"k510_count":59},"DKT","Free Radical Assay, Opiates",{"product_code":167,"device_name":168,"device_class":8,"k510_count":59},"LAH","High Pressure Liquid Chromatography, Opiates",{"510k":170,"classification":171,"enforcement":172,"event":173,"pma":174,"warning_letter":175},"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"]