ATAC HEMOGLOBIN A1C REAGENT KIT— 510(k) K031042

Substantially Equivalent

Clinical Data, Inc.

FDA 510(k) clearance K031042 for ATAC HEMOGLOBIN A1C REAGENT KIT, Substantially Equivalent on 2003-11-03. Applicant: Clinical Data, Inc..

Clearance details

Applicant: Clinical Data, Inc.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2003-04-01
Decision date: 2003-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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