DeviceClearance

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

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.

Clearance details

Applicant
Aesku Systems GmbH&Co.Kg
Product code
Code DHN
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Wendelsheim, DE
Download summary PDFView on FDA.gov ↗

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