Cleared Traditional

EUROIMMUN ANTI-NRNP/SM ELISA (IGG)

K123261 · Euroimmun US · Immunology
Jun 2013
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K123261 is an FDA 510(k) clearance for the EUROIMMUN ANTI-NRNP/SM ELISA (IGG), a Anti-rnp Antibody, Antigen And Control (Class II — Special Controls, product code LKO), submitted by Euroimmun US (Morris Plains, US). The FDA issued a Cleared decision on June 12, 2013, 237 days after receiving the submission on October 18, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K123261 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2012
Decision Date June 12, 2013
Days to Decision 237 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LKO — Anti-rnp Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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