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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK250727
Test Name Medical Distribution Group Inc., Identify Health Multi-Drug Urine Test Cup  
Manufacturer NameHangzhou AllTest Biotech Co., Ltd.
Consumer Information Phone Number1(888)600-0431
Test TypeMethamphetamines
Effective Date05/09/2025
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K250727
Device Name AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup
Applicant
Hangzhou AllTest Biotech Co., Ltd.
#550 Yinhai St.
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
Correspondent
LSI International, Inc.
504e Diamond Ave.
Suite H
Gaithersburg,  MD  20877
Correspondent Contact Jenny Xia
Regulation Number862.3100
Classification Product Code
NFT  
Subsequent Product Codes
NFV   NFW   NFY   NGG   NGL  
NGM   PTG   PTH   QAW   QBF  
Date Received03/11/2025
Decision Date 04/04/2025
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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