Cleared Traditional

ARKIT HBA1C

K030553 · Arkray, Inc. · Chemistry
Sep 2003
Decision
193d
Days
Class 2
Risk

About This 510(k) Submission

K030553 is an FDA 510(k) clearance for the ARKIT HBA1C, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Arkray, Inc. (Wilmington, US). The FDA issued a Cleared decision on September 2, 2003, 193 days after receiving the submission on February 21, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K030553 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2003
Decision Date September 02, 2003
Days to Decision 193 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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