AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM— 510(k) K153117

Name: FDA 510(k) clearance K153117
Creator: U.S. Food and Drug Administration
Published: 2016-07-28

Substantially Equivalent

Aesku Systems GmbH&Co.Kg

FDA 510(k) clearance K153117 for AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM, Substantially Equivalent on 2016-07-28. Applicant: Aesku Systems GmbH&Co.Kg. Device class: 2.

Clearance details

Applicant: Aesku Systems GmbH&Co.Kg
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2015-10-28
Decision date: 2016-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wendelsheim, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.