RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050


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

Correspodent Contact natalie j kennel
Regulation Number 862.3610
Classification Product Code
LAF  
Date Received 02/20/2008
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