ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY


Device Classification Name

assay, glycosylated hemoglobin

510(k) Number K110934
Device Name ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
333 coney street
walpole, 
MA 
02032 -1516

Applicant Contact sandra d white
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
333 coney street
walpole, 
MA 
02032 -1516

Correspodent Contact sandra d white
Regulation Number 864.7470
Classification Product Code
LCP  
Date Received 04/04/2011
Decision Date 08/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No