Clearance Summary
Kenota 1 Total IgE; Kenota 1 (instrument) received FDA 510(k) clearance under submission number K231151, sponsored by Kenota, Inc.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2024-05-31.
- Submission: K231151
- Applicant / Sponsor: Kenota, Inc.
- Clearance pathway: Dual Track
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2024-05-31
Classification & Regulation
This clearance is catalogued under FDA product code DGC and 21 CFR 866.5510, within the Immunology review panel as a Class II device.