SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS


Device Classification Name

enzymatic method, alcohol dehydrogenase, ultraviolet

510(k) Number K000410
Device Name SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
Original Applicant
BECKMAN COULTER, INC.
200 s. kraemer blvd.,m/s w-104
box 8000
brea, 
CA 
92822 -8000

Original Contact lucinda stockert
Regulation Number 862.3040
Classification Product Code
DMT  
Subsequent Product Code
DNN  
Date Received 02/08/2000
Decision Date 04/10/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No