Clearance Summary
BOND MMR Antibody Panel received FDA 510(k) clearance under submission number K213348, sponsored by Leica Biosystems Newcastle, 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 2023-02-21.
- Submission: K213348
- Applicant / Sponsor: Leica Biosystems Newcastle, Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 864.1866
- Decision date: 2023-02-21
Classification & Regulation
This clearance is catalogued under FDA product code PZJ and 21 CFR 864.1866, within the Immunology review panel as a Class II device.