ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K023712
Device Name ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
Original Applicant
ADVANTAGE DIAGNOSTICS CORP
764 san aleso ave.
sunnyvale, 
CA 
94085

Original Contact janis freestone
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJC   DJG   LCM   LDK  
Date Received 11/04/2002
Decision Date 01/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No