Cleared Traditional

AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS

K072686 · Axis-Shield Diagnostics, Ltd. · Chemistry
Mar 2008
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K072686 is an FDA 510(k) clearance for the AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS, 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 March 17, 2008, 175 days after receiving the submission on September 24, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K072686 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2007
Decision Date March 17, 2008
Days to Decision 175 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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