Cleared Special

LIAISON? EA IgG and LIAISON? EA IgG Serum Control Set

K162959 · DiaSorin, Inc. · Microbiology
Jan 2017
Decision
72d
Days
Class 1
Risk

About This 510(k) Submission

K162959 is an FDA 510(k) clearance for the LIAISON? EA IgG and LIAISON? EA IgG Serum Control Set, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by DiaSorin, Inc. (Stillwater,, US). The FDA issued a Cleared decision on January 4, 2017, 72 days after receiving the submission on October 24, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K162959 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2016
Decision Date January 04, 2017
Days to Decision 72 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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