URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A


codes

Device Classification Name

enzyme immunoassay, opiates

510(k) Number K000464
Device Name URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
Original Applicant
DADE BEHRING, INC.
rt. 896, glascow bldg. 500
newark, 
DE 
19714

Original Contact judy mcinnis-berger
Regulation Number 862.3650
Classification Product Code
DJG  
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