Cleared Traditional

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

K153117 · Aesku Systems GmbH&Co.Kg · Immunology

Jul 2016

Decision

274d

Days

Class 2

Risk

About This 510(k) Submission

K153117 is an FDA 510(k) clearance for the AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Aesku Systems GmbH&Co.Kg (Wendelsheim, DE). The FDA issued a Cleared decision on July 28, 2016, 274 days after receiving the submission on October 28, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K153117 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2015
Decision Date	July 28, 2016
Days to Decision	274 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5100