Cleared Traditional

ANA SCREEN ELISA (IGG)

K131185 · Euroimmun US · Immunology
Jul 2013
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K131185 is an FDA 510(k) clearance for the ANA SCREEN ELISA (IGG), a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on July 15, 2013, 80 days after receiving the submission on April 26, 2013. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K131185 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2013
Decision Date July 15, 2013
Days to Decision 80 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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