Cleared Traditional

ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)

K160757 · Axis-Shield Diagnostics Limited · Chemistry

Jul 2016

Decision

130d

Days

Class 2

Risk

About This 510(k) Submission

K160757 is an FDA 510(k) clearance for the ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM), a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Axis-Shield Diagnostics Limited (Dundee, Scotland, GB). The FDA issued a Cleared decision on July 26, 2016, 130 days after receiving the submission on March 18, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number	K160757 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 2016
Decision Date	July 26, 2016
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF