ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY— 510(k) K110934

Substantially Equivalent

Siemens Healthcare Diagnostics

FDA 510(k) clearance K110934 for ADVIA CHEMISTRY HEMOGLOBIN A1C_3 (A1C_3) AUTOMATED PRETREATMENT ASSAY, Substantially Equivalent on 2011-08-25. Applicant: Siemens Healthcare Diagnostics.

Clearance details

Applicant: Siemens Healthcare Diagnostics
Product code: Code LCP
Advisory panel: Hematology
Date received: 2011-04-04
Decision date: 2011-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.