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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK252867
Test Name RODIMEDI & ASSOCIATES INC., RED TUNICA DOPI Multi-Drug Detection System  
Manufacturer NameAdvin Biotech, Inc.
Consumer Information Phone Number1(888)315-9472
Test TypeFentanyl
Effective Date05/04/2026
Device Classification Name Test, Amphetamine, Over The Counter
510(k) Number K252867
Device Name VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test Cup
Applicant
Advin Biotech, Inc.
10140 Mesa Rim Rd. Unit 1
San Diego,  CA  92121
Applicant Contact Ding Wei
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   QBF  
Date Received09/09/2025
Decision Date 10/09/2025
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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