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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK202567
Test Name Micro Distributing, STATDIP One Step Drug Test  
Manufacturer NameGuangzhou Wondfo Biotech Co., Ltd.
Consumer Information Phone Number1(866)933-0964
Test TypeMethylenedioxymethamphetamine (MDMA)
Effective Date06/07/2022
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.
No. 8 Lizhishan Road, 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
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