ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM


Device Classification Name

bromcresol green dye-binding, albumin

510(k) Number K991576
Device Name ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
Applicant
BAYER CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Applicant Contact gabriel j muraca
Correspondent
BAYER CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Correspodent Contact gabriel j muraca
Regulation Number 862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CDQ   CEO   CFO   CFR   CGA  
CGS   CGX   CIC   CIG   CIT   CJK  
JFY   JIY   KHM   KNK   LBS  
Date Received 05/06/1999
Decision Date 06/30/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No