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Document NumberK040629/A003
Test Name Instant Technologies OTC iTest for Drugs Of Abuse, iCassette Home Drug Test For Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates And Phencyclidine  
Manufacturer NameACCU-STAT DIAGNOSTICS, INC.
Consumer Information Phone Number(888)741-3600
Test TypeAmphetamines
Effective Date06/15/2006
Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K040629
Device Name ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
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 Received03/10/2004
Decision Date 05/05/2004
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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