Cleared Traditional

EUROIMMUN ANTI-ENA POOL ELISA (IGG)

K112996 · Euroimmun US · Immunology
Apr 2013
Decision
550d
Days
Class 2
Risk

About This 510(k) Submission

K112996 is an FDA 510(k) clearance for the EUROIMMUN ANTI-ENA POOL ELISA (IGG), a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on April 9, 2013, 550 days after receiving the submission on October 7, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K112996 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2011
Decision Date April 09, 2013
Days to Decision 550 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LLL — Extractable Antinuclear Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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