Cleared Traditional

DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS

K053411 · Microgenics Corp. · Chemistry
Feb 2006
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K053411 is an FDA 510(k) clearance for the DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on February 3, 2006, 58 days after receiving the submission on December 7, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K053411 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2005
Decision Date February 03, 2006
Days to Decision 58 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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