Clearance Summary
Beta-2-Microglobulin received FDA 510(k) clearance under submission number K161297, sponsored by Beckman Coulter Ireland, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2016-06-07.
- Submission: K161297
- Applicant / Sponsor: Beckman Coulter Ireland, Inc.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5630
- Decision date: 2016-06-07
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.