RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K080436
Device Name RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052
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 862.3250
Classification Product Code
DIO  
Date Received 02/19/2008
Decision Date 02/11/2009
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