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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK241428
Test Name BTNX Inc., Rapid Response Drug Screen Cup  
Manufacturer NameHangzhou AllTest Biotech Co., Ltd.
Consumer Information Phone Number1(888)339-9964
Test TypeMethadone
Effective Date09/11/2024
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K241428
Device Name AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup
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 Received05/20/2024
Decision Date 06/17/2024
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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