ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR


Device Classification Name

calibrator, secondary

510(k) Number K021535
Device Name ADVIA CANTAUR AND ACS:180 INSULIN CALIBRATOR
Original Applicant
BAYER DIAGNOSTICS CORP.
511 benedict ave.
tarrytown, 
NY 
10591 -5097

Original Contact kenneth t edds
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 05/10/2002
Decision Date 06/27/2002
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