Clearance Summary
HUMAN ALPHA2-MACROGLOBULIN KIT FOR USE ON SPAPLUS received FDA 510(k) clearance under submission number K140664, 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 2014-04-16.
- Submission: K140664
- Applicant / Sponsor: The Binding Site Group , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5620
- Decision date: 2014-04-16
Classification & Regulation
This clearance is catalogued under FDA product code DEB and 21 CFR 866.5620, within the Immunology review panel as a Class II device.