Cleared Traditional

AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin

K172461 · Aesku.Diagnostics GmbH & Co. KG · Immunology
Mar 2018
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K172461 is an FDA 510(k) clearance for the AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin, a Test System, Antineutrophil Cytoplasmic Antibodies (anca) (Class II — Special Controls, product code MOB), submitted by Aesku.Diagnostics GmbH & Co. KG (Wendelsheim, DE). The FDA issued a Cleared decision on March 23, 2018, 221 days after receiving the submission on August 14, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K172461 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2017
Decision Date March 23, 2018
Days to Decision 221 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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