Cleared Special

ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay

K172133 · Axis-Shield Diagnostics, Ltd. · Chemistry
Oct 2017
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K172133 is an FDA 510(k) clearance for the ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay, a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on October 27, 2017, 105 days after receiving the submission on July 14, 2017. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K172133 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2017
Decision Date October 27, 2017
Days to Decision 105 days
Submission Type Special
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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