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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK252550
Test Name Wondfo USA Co., Ltd., SAFElife C-Cup Multi-Drug Urine Test Cup  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypeTramadol
Effective Date01/26/2026
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K252550
Device Name SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup 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 Received08/13/2025
Decision Date 11/18/2025
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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