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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Predetermined Change
Control Plan Authorized		 No
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