URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A


information about

Device Classification Name

enzyme immunoassay, cocaine and cocaine metabolites

510(k) Number K000467
Device Name URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
Original Applicant
DADE BEHRING, INC.
rt. 896, glascow bldg. 500
newark, 
DE 
19714

Original Contact judy mcinnis-berger
Regulation Number 862.3250
Classification Product Code
DIO  
Date Received 02/11/2000
Decision Date 04/14/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No