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U.S. Department of Health and Human Services

OTC - Over The Counter
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Document NumberK040327/A005
Test Name Instant Technologies OTC Inc. iTest for Drugs of Abuse, iCassette Home Drug Test for Marijuana and Cocaine (THC, COC)  
Manufacturer NameACCU-STAT DIAGNOSTICS, INC.
Consumer Information Phone Number(888)741-3600
Test TypeCannabinoids (THC)
Effective Date08/08/2006
Device Classification Name Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
510(k) Number K040327
Device Name ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
Applicant
ACCU-STAT DIAGNOSTICS, INC.
11 ORCHARD RD., SUITE 108
LAKE FOREST,  CA  92630
Applicant Contact JAMES G BARRONS
Correspondent
ACCU-STAT DIAGNOSTICS, INC.
11 ORCHARD RD., SUITE 108
LAKE FOREST,  CA  92630
Correspondent Contact JAMES G BARRONS
Classification Product Code
MVO  
Subsequent Product Codes
DIO   LDJ  
Date Received02/10/2004
Decision Date 04/19/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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