Cleared Traditional

ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)

K112443 · Axis-Shield Diagnostics, Ltd. · Chemistry
Dec 2011
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K112443 is an FDA 510(k) clearance for the ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN), a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on December 19, 2011, 117 days after receiving the submission on August 24, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K112443 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2011
Decision Date December 19, 2011
Days to Decision 117 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDD — Radioassay, Vitamin B12
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1810

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