Cleared Traditional

EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS

K083850 · Euroimmun Us, Inc. · Immunology
May 2009
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K083850 is an FDA 510(k) clearance for the EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS, 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 May 20, 2009, 147 days after receiving the submission on December 24, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K083850 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 2008
Decision Date May 20, 2009
Days to Decision 147 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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