Cleared Traditional

EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG)

K082130 · Euroimmun Us, Inc. · Immunology
Apr 2009
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K082130 is an FDA 510(k) clearance for the EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG), a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on April 7, 2009, 252 days after receiving the submission on July 29, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K082130 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2008
Decision Date April 07, 2009
Days to Decision 252 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MOB — Test System, Antineutrophil Cytoplasmic Antibodies (anca)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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