Clearance Summary
Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit received FDA 510(k) clearance under submission number K250549, 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 2025-05-23.
- Submission: K250549
- Applicant / Sponsor: The Binding Site Group , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 2025-05-23
Classification & Regulation
This clearance is catalogued under FDA product code DFH and 21 CFR 866.5550, within the Immunology review panel as a Class II device.