Clearance Summary
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit received FDA 510(k) clearance under submission number K160819, 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 2016-06-16.
- Submission: K160819
- 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: 2016-06-16
Classification & Regulation
This clearance is catalogued under FDA product code OPX and 21 CFR 866.5510, within the Immunology review panel as a Class II device.