Clearance Summary
Rheumatoid Factor (RF) Kit for use on SPAPLUS received FDA 510(k) clearance under submission number K160070, 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 2016-12-07.
- Submission: K160070
- Applicant / Sponsor: The Binding Site Group , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5775
- Decision date: 2016-12-07
Classification & Regulation
This clearance is catalogued under FDA product code DHR and 21 CFR 866.5775, within the Immunology review panel as a Class II device.