Cleared Traditional

ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C

K121842 · Axis-Shield Diagnostics, Ltd. · Chemistry
Dec 2012
Decision
170d
Days
Class 2
Risk

About This 510(k) Submission

K121842 is an FDA 510(k) clearance for the ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on December 12, 2012, 170 days after receiving the submission on June 25, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K121842 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2012
Decision Date December 12, 2012
Days to Decision 170 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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