URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A


codes

Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K000460
Device Name URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A
Original Applicant
DADE BEHRING, INC.
rt. 896, glascow bldg. 500
newark, 
DE 
19714

Original Contact judy mcinnis-berger
Regulation Number 862.3100
Classification Product Code
DKZ  
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