Cleared Traditional

AESKU PR3

K091859 · Aesku Diagnostics · Immunology
Jun 2010
Decision
349d
Days
Class 2
Risk

About This 510(k) Submission

K091859 is an FDA 510(k) clearance for the AESKU PR3, 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 June 3, 2010, 349 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 K091859 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2009
Decision Date June 03, 2010
Days to Decision 349 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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