Cleared Traditional

AESKULISA MPO, MODEL 30-7303US

K091860 · Aesku Diagnostics · Immunology
Feb 2010
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K091860 is an FDA 510(k) clearance for the AESKULISA MPO, MODEL 30-7303US, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Aesku Diagnostics (Wendelsheim, Rheinland, DE). The FDA issued a Cleared decision on February 23, 2010, 249 days after receiving the submission on June 19, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K091860 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2009
Decision Date February 23, 2010
Days to Decision 249 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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