ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491


Device Classification Name

calibrator, secondary

510(k) Number K103548
Device Name ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
Applicant
Siemens Healthcare Diagnostics Inc.
333 coney street
east walpole, 
MA 
02032

Applicant Contact sandra d white
Correspondent
Siemens Healthcare Diagnostics Inc.
333 coney street
east walpole, 
MA 
02032

Correspodent Contact sandra d white
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 12/03/2010
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No