Cleared Traditional

ATAC HEMOGLOBIN A1C REAGENT KIT

K031042 · Clinical Data, Inc. · Chemistry
Nov 2003
Decision
216d
Days
Class 2
Risk

About This 510(k) Submission

K031042 is an FDA 510(k) clearance for the ATAC HEMOGLOBIN A1C REAGENT KIT, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Clinical Data, Inc. (Brea, US). The FDA issued a Cleared decision on November 3, 2003, 216 days after receiving the submission on April 1, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K031042 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2003
Decision Date November 03, 2003
Days to Decision 216 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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