AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
K-Number: K153117 · 2016-07-28
Device Summary
Frequently Asked Questions
What is the AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM?
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Aesku Systems GmbH&Co.Kg. The 510(k) number is K153117.
When did AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM receive FDA 510(k) clearance?
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM received FDA 510(k) clearance on 2016-07-28, under 510(k) number K153117.
Who is the listed applicant for AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM?
The FDA 510(k) record lists Aesku Systems GmbH&Co.Kg as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM?
The FDA product code for AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM is DHN.
Related Devices (Code: DHN)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.