BAYER SPECIAL CHEMISTRY CALIBRATORS

Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K033380
Device Name BAYER SPECIAL CHEMISTRY CALIBRATORS
Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Applicant Contact andres holle
Correspondent
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Correspodent Contact andres holle
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 10/22/2003
Decision Date 12/16/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No