Clearance Summary
Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit received FDA 510(k) clearance under submission number K173732, 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 2018-08-23.
- Submission: K173732
- 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: 2018-08-23
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.