BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM

Device Classification Name

enzyme immunoassay, digoxin

510(k) Number K033007
Device Name BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM
Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Applicant Contact kenneth t edds
Correspondent
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Correspodent Contact kenneth t edds
Regulation Number 862.3320
Classification Product Code
KXT  
Date Received 09/26/2003
Decision Date 11/14/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No