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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK242540
Test Name ABOUND Diagnostics, Inc., CHOSEN Multi-Drug Rapid Urine Test Panel  
Manufacturer NameHangzhou AllTest Biotech Co., Ltd.
Consumer Information Phone Number1(888)969-6928
Test TypeFentanyl
Effective Date04/30/2025
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 St.
Hangzhou,  CN 310018
Applicant Contact Rosa Wu
Correspondent
LSI International, Inc.
504 E 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
Predetermined Change
Control Plan Authorized		 No
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