BAYER ADVIA CENTAUR HER-2/NEU ASSAY


Device Classification Name

system, test, her-2/neu, monitoring

510(k) Number K024017
Device Name BAYER ADVIA CENTAUR HER-2/NEU ASSAY
Original Applicant
BAYER CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact kenneth t edds
Regulation Number 866.6010
Classification Product Code
NCW  
Date Received 12/04/2002
Decision Date 01/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No