Cleared Traditional

Access Vitamin B12

K223289 · Beckman Coulter, Inc. · Chemistry
Dec 2022
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K223289 is an FDA 510(k) clearance for the Access Vitamin B12, a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 23, 2022, 59 days after receiving the submission on October 25, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K223289 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2022
Decision Date December 23, 2022
Days to Decision 59 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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