Clearance Summary
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS received FDA 510(k) clearance under submission number K122066, sponsored by The Binding Site Group , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2012-08-30.
- Submission: K122066
- Applicant / Sponsor: The Binding Site Group , Ltd.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5630
- Decision date: 2012-08-30
Classification & Regulation
This clearance is catalogued under FDA product code JZG and 21 CFR 866.5630, within the Immunology review panel as a Class II device.