Clearance Summary
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII received FDA 510(k) clearance under submission number K140105, sponsored by The Binding Site. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2014-03-18.
- Submission: K140105
- Applicant / Sponsor: The Binding Site
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2014-03-18
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.