ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR


Device Classification Name

system, test, beta-2-microglobulin immunological

510(k) Number K110874
Device Name ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown, 
NY 
10591

Applicant Contact neil parker
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
511 benedict ave
tarrytown, 
NY 
10591

Correspodent Contact neil parker
Regulation Number 866.5630
Classification Product Code
JZG  
Subsequent Product Code
JIT  
Date Received 03/29/2011
Decision Date 01/20/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No