Clearance Summary
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM received FDA 510(k) clearance under submission number K153117, sponsored by Aesku Systems GmbH&Co.Kg. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2016-07-28.
- Submission: K153117
- Applicant / Sponsor: Aesku Systems GmbH&Co.Kg
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2016-07-28
Classification & Regulation
This clearance is catalogued under FDA product code DHN and 21 CFR 866.5100, within the Immunology review panel as a Class II device.