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

Name: FDA 510(k) clearance K053411
Creator: U.S. Food and Drug Administration
Published: 2006-02-03

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.. Device class: 2.

Clearance details

Applicant: Microgenics Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2005-12-07
Decision date: 2006-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont Blvd., CA, US

Download summary PDF View on FDA.gov ↗

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