RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054


Device Classification Name

enzyme immunoassay, phencyclidine

510(k) Number K080431
Device Name RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054
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 862.3100
Classification Product Code
LCM  
Date Received 02/19/2008
Decision Date 01/08/2009
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