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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK242540
Test Name American Screening Corp., PRECISION PLUS Multi-Panel Rapid Urine Test Card  
Manufacturer NameHangzhou Alltest Biotech Co.,Ltd
Consumer Information Phone Number1(888)251-4044
Test TypeCocaine metabolites
Effective Date04/15/2025
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K242540
Device Name AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel
Applicant
Hangzhou Alltest Biotech Co.,Ltd
#550, Yinhai Street
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  
Date Received08/26/2024
Decision Date 09/27/2024
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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