SETPOINT CHEMISTRY CALIBRATOR


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K030169
Device Name SETPOINT CHEMISTRY CALIBRATOR
Original Applicant
BAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown, 
NY 
10591

Original Contact kenneth t edds
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 01/17/2003
Decision Date 01/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No