Cleared Traditional

MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS

K033674 · Seradyn, Inc. · Chemistry
Feb 2004
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K033674 is an FDA 510(k) clearance for the MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 9, 2004, 77 days after receiving the submission on November 24, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K033674 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2003
Decision Date February 09, 2004
Days to Decision 77 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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