ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K103701
Device Name ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown, 
NY 
10591

Applicant Contact kira gordon
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown, 
NY 
10591

Correspodent Contact kira gordon
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 12/20/2010
Decision Date 02/18/2011
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