Cleared Traditional

LIAISON Vitamin B12

K192064 · DiaSorin, Inc. · Chemistry
Oct 2019
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K192064 is an FDA 510(k) clearance for the LIAISON Vitamin B12, a Radioassay, Vitamin B12 (Class II — Special Controls, product code CDD), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on October 2, 2019, 62 days after receiving the submission on August 1, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K192064 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2019
Decision Date October 02, 2019
Days to Decision 62 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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