Cleared Traditional

ARCHITECT Active-B12 (Holotranscobalamin)

K233541 · Axis-Shield Diagnostics, Ltd. · Chemistry
Jul 2024
Decision
271d
Days
Class 2
Risk

About This 510(k) Submission

K233541 is an FDA 510(k) clearance for the ARCHITECT Active-B12 (Holotranscobalamin), 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 July 31, 2024, 271 days after receiving the submission on November 3, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K233541 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 2023
Decision Date July 31, 2024
Days to Decision 271 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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