ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM


Device Classification Name

alcohol dehydrogenase, specific reagent for ethanol enzyme method

510(k) Number K023184
Device Name ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
Original Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact kenneth t edds
Regulation Number 862.3040
Classification Product Code
DIC  
Subsequent Product Code
JIX  
Date Received 09/24/2002
Decision Date 11/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No