URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A


Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K033713
Device Name URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A
Applicant
DADE BEHRING, INC.
p.o. box 6101 building 500
glasgow business community
newark,, 
DE 
19714

Applicant Contact andrea m tasker
Correspondent
DADE BEHRING, INC.
p.o. box 6101 building 500
glasgow business community
newark,, 
DE 
19714

Correspodent Contact andrea m tasker
Regulation Number 862.3250
Classification Product Code
DIO  
Date Received 11/26/2003
Decision Date 02/09/2004
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