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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Opiates, Over The Counter
510(k) Number K242428
Device Name Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
Applicant
Guangzhou Decheng Biotechnology Co., Ltd.
Floor 3/4/5/7, Bldg. A1, # 12 Nanyun 1st Rd.
Science City, Huangpu District
Guangzhou,  CN 510663
Applicant Contact Jenny Mao
Correspondent
Guangzhou Decheng Biotechnology Co., Ltd.
Floor 3/4/5/7, Bldg. A1, # 12 Nanyun 1st Rd.
Science City, Huangpu District
Guangzhou,  CN 510663
Correspondent Contact Jenny Mao
Regulation Number862.3650
Classification Product Code
NGL  
Date Received08/15/2024
Decision Date 02/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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