Cleared Traditional

LIAISON VZV IgG HT, LIAISON Control VZV IgG HT

K231214 · DiaSorin, Inc. · Microbiology
Oct 2023
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K231214 is an FDA 510(k) clearance for the LIAISON VZV IgG HT, LIAISON Control VZV IgG HT, a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II — Special Controls, product code LFY), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on October 27, 2023, 182 days after receiving the submission on April 28, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K231214 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 2023
Decision Date October 27, 2023
Days to Decision 182 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3900

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