ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3


Device Classification Name

enzyme controls (assayed and unassayed)

510(k) Number K030102
Device Name ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
Original Applicant
BAYER HEALTHCARE, LLC
511 benedict ave.
tarrytown, 
NY 
10591

Original Contact kenneth t edds
Regulation Number 862.1660
Classification Product Code
JJT  
Date Received 01/10/2003
Decision Date 01/24/2003
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