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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
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