URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A


the company

Device Classification Name

enzyme immunoassay, barbiturate

510(k) Number K000459
Device Name URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A
Original Applicant
DADE BEHRING, INC.
rt. 896, glascow bldg. 500
newark, 
DE 
19714

Original Contact judy mcinnis-berger
Regulation Number 862.3150
Classification Product Code
DIS  
Date Received 02/11/2000
Decision Date 04/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No