Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

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

K-Number: K153117 · 2016-07-28

ApplicantAesku Systems GmbH&Co.Kg
Decision Date2016-07-28
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM is a medical device manufactured by Aesku Systems GmbH&Co.Kg. It received FDA 510(k) clearance on 2016-07-28 under approval number K153117. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

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. It is manufactured by Aesku Systems GmbH&Co.Kg. The 510(k) number is K153117.

When was AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM approved by the FDA?

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM received FDA 510(k) clearance on 2016-07-28, under approval number K153117.

What company makes AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM?

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM is manufactured by Aesku Systems GmbH&Co.Kg.

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 Clinical Trials

NCT03053791 Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait RECRUITING NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING

Related Devices (Code: DHN)

K160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd. K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc. K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.

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.

↑