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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 K250067
Device Name Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
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 Mango Huang
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 Mango Huang
Regulation Number862.3650
Classification Product Code
NGL  
Subsequent Product Codes
NFT   NFV   NFW   NFY   NGG  
NGM   PTG   PTH   QAW   QBF  
Date Received01/10/2025
Decision Date 02/20/2025
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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