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OTC - Over The Counter
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Document NumberK122809
Test Name CLIAwaived, INC., Test yourself @home Instant Drug Test Cup  
Manufacturer NameADVIN BIOTECH
Consumer Information Phone Number1(888)882-7739
Test TypeAmphetamines
Effective Date01/10/2025
Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K122809
Device Name ADVIN MULTI-DRUG SCREEN TEST CASSETTE, DIP CARD AND CUP
Applicant
ADVIN BIOTECH
6861 NANCY RIDGE DR.
SAN DIEGO,  CA  92121
Applicant Contact EDWARD TUNG
Correspondent
ADVIN BIOTECH
6861 NANCY RIDGE DR.
SAN DIEGO,  CA  92121
Correspondent Contact EDWARD TUNG
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   JXN   LCM   LDJ   LFG  
Date Received09/13/2012
Decision Date 06/17/2013
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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