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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatography, Methamphetamine
510(k) Number K080455
Device Name RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050
Applicant
Quantrx Biomedical Corporation
13721 Via Tres Vista
San Diego,  CA  92129
Applicant Contact NATALIE J KENNEL
Correspondent
Quantrx Biomedical Corporation
13721 Via Tres Vista
San Diego,  CA  92129
Correspondent Contact NATALIE J KENNEL
Regulation Number862.3610
Classification Product Code
LAF  
Date Received02/20/2008
Decision Date 12/31/2008
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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