URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A


Device Classification Name

enzyme immunoassay, phencyclidine

510(k) Number K000462
Device Name URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A
Original Applicant
DADE BEHRING, INC.
rt. 896, glascow bldg. 500
newark, 
DE 
19714

Original Contact judy mcinnis-berger
Regulation Number 862.3100
Classification Product Code
LCM  
Date Received 02/11/2000
Decision Date 04/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No