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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K261409
Device Name BioTeke® Multi-Drug Urine Test Cup
Applicant
Bioteke Corporation (Wuxi) Co., Ltd.
# 90, Huiming Rd.,Huishan,Wuxi City,Jiangsu,214000,China
4th Floor, D5, #1719,Huishan Ave. Wuxi, Jiangsu, 214174, Chi
Wuxi,  CN 214000
Applicant Contact Zhitu Zhou
Correspondent
Bioteke Corporation (Wuxi) Co., Ltd.
4th floor, D5, No.1719, Huishan Avenue
Wuxi City,  CN 214174
Correspondent Contact Zhitu Zhou
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
NFV   NFW   NFY   NGG   NGL  
NGM   PTG   PTH   QAW  
Date Received04/30/2026
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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