Clearance Summary
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit received FDA 510(k) clearance under submission number K152389, 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 2015-12-18.
- Submission: K152389
- 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: 2015-12-18
Classification & Regulation
This clearance is catalogued under FDA product code PDE and 21 CFR 866.5510, within the Immunology review panel as a Class II device.