Cleared Traditional

A/C ENZYMATIC VITAMIN B6 ASSAY

K111260 · Anticancer, Inc. · Chemistry
Jul 2012
Decision
448d
Days
Class 2
Risk

About This 510(k) Submission

K111260 is an FDA 510(k) clearance for the A/C ENZYMATIC VITAMIN B6 ASSAY, a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Anticancer, Inc. (San Diego, US). The FDA issued a Cleared decision on July 26, 2012, 448 days after receiving the submission on May 5, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K111260 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2011
Decision Date July 26, 2012
Days to Decision 448 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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