Clearance Summary
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS received FDA 510(k) clearance under submission number K161854, 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 2016-10-04.
- Submission: K161854
- 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: 2016-10-04
Classification & Regulation
This clearance is catalogued under FDA product code PCN and 21 CFR 866.5510, within the Immunology review panel as a Class II device.