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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK202567
Test Name Wondfo USA Co., Ltd., SAFElife T-Dip Buprenorphine (BUP) Urine Test Panel  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(888)444-3657
Test TypeBuprenorphine
Effective Date10/30/2023
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K202567
Device Name Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx
Applicant
Guangzhou Wondfo Biotech Co., Ltd.
# 8 Lizhishan Rd., Science City
Guangzhou,  CN 510641
Applicant Contact Yi Mei
Correspondent
Lsi International
504 E. Diamond Ave., Suite I
Gaithersburg,  MD  20877
Correspondent Contact Joe Shia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
LCM   NFV   NFW   NFY   NGG  
NGL   PTG   PTH   QAW   QBF  
Date Received09/04/2020
Decision Date 09/25/2020
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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