ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K072204
Device Name ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591

Applicant Contact philip liu
Correspondent
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
511 benedict avenue
tarrytown, 
NY 
10591

Correspodent Contact philip liu
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 08/08/2007
Decision Date 10/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No

Combination Product

No