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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK233062
Test Name BTNX Inc., Rapid Response Home Drug Monitoring Panel  
Manufacturer NameVivachek Biotech (Hangzhou) Co., Ltd.
Consumer Information Phone Number1(888)969-6928
Test TypeMethadone
Effective Date06/17/2025
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K233062
Device Name BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
Applicant
Vivachek Biotech (Hangzhou) Co., Ltd.
Level 2, Block 2, 146 E. Chaofeng Rd.
Yuhang Economy Development Zone
Hangzhou,  CN 311100
Applicant Contact Jessica Chen
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 Received09/26/2023
Decision Date 11/02/2023
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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