CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM


Device Classification Name

test, epithelial ovarian tumor-associated antigen (ca125)

510(k) Number K022329
Device Name CA 125 II 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 866.6010
Classification Product Code
LTK  
Date Received 07/18/2002
Decision Date 11/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No