Clearance Summary
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 received FDA 510(k) clearance under submission number K172348, sponsored by Aesku.Diagnostics 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 2018-02-16.
- Submission: K172348
- Applicant / Sponsor: Aesku.Diagnostics GmbH & Co. KG
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2018-02-16
Classification & Regulation
This clearance is catalogued under FDA product code LSW and 21 CFR 866.5100, within the Immunology review panel as a Class II device.