Cleared Special

LIAISON EBV IgM Serum Control Set

K161522 · DiaSorin, Inc. · Microbiology
Jun 2016
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K161522 is an FDA 510(k) clearance for the LIAISON EBV IgM Serum Control Set, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on June 30, 2016, 28 days after receiving the submission on June 2, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K161522 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2016
Decision Date June 30, 2016
Days to Decision 28 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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