Cleared Traditional

EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG)

K140224 · Euroimmun US · Immunology
Dec 2014
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K140224 is an FDA 510(k) clearance for the EUROIMMUN EUROLINE ENA PROFILE 9AG (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 December 9, 2014, 314 days after receiving the submission on January 29, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K140224 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 2014
Decision Date December 09, 2014
Days to Decision 314 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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