DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS— 510(k) K053411

Substantially Equivalent

Microgenics Corp.

FDA 510(k) clearance K053411 for DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS, Substantially Equivalent on 2006-02-03. Applicant: Microgenics Corp..

Clearance details

Applicant: Microgenics Corp.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2005-12-07
Decision date: 2006-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

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