Clearance Summary
Immunoglobulin Isotypes (GAM) for the EXENT Analyser; EXENT Analyser received FDA 510(k) clearance under submission number K250159, sponsored by The Binding Site Group , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2025-10-17.
- Submission: K250159
- Applicant / Sponsor: The Binding Site Group , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2025-10-17
Classification & Regulation
This clearance is catalogued under FDA product code SGG and 21 CFR 866.5510, within the Immunology review panel as a Class II device.