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Document NumberK041221/A001
Test Name Instant Technologies OTC iTest for Drugs Of Abuse, iCup Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, And Phencyclidine  
Manufacturer NameACCU-STAT DIAGNOSTICS, INC.
Consumer Information Phone Number(888)741-3600
Test TypeCannabinoids (THC)
Effective Date06/15/2006
Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K041221
Device Name ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
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
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DJG   DKZ   LAF   LCM  
MVO  
Date Received05/10/2004
Decision Date 07/13/2004
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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