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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 K260065
Device Name SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
#8 Lizhishan Rd., Science City, Huangpu District
Guangzhou,  CN 510663
Applicant Contact Kaiyu Xiao
Correspondent
Guangzhou Wondfo Biotech Co., Ltd.
#8 Lizhishan Rd., Science City, Huangpu District
Guangzhou,  CN 510663
Correspondent Contact Kaiyu Xiao
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
LCM   NFV   NFW   NFY   NGG  
NGL   PTG   PTH   QAW   QBF  
Date Received01/09/2026
Decision Date 04/28/2026
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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