Cleared Traditional

AXIS-SHIELD ACVTIVE-B12

K121946 · Axis-Shield Diagnostics, Ltd. · Chemistry
Mar 2013
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K121946 is an FDA 510(k) clearance for the AXIS-SHIELD ACVTIVE-B12, 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 March 22, 2013, 262 days after receiving the submission on July 3, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K121946 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2012
Decision Date March 22, 2013
Days to Decision 262 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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