Cleared Special

LIAISON VZV IgG, LIAISON Control VZV IgG

K150375 · DiaSorin, Inc. · Microbiology
Mar 2015
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K150375 is an FDA 510(k) clearance for the LIAISON VZV IgG, LIAISON Control VZV IgG, 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 March 11, 2015, 26 days after receiving the submission on February 13, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K150375 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2015
Decision Date March 11, 2015
Days to Decision 26 days
Submission Type Special
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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