Clearance Summary
Xpert® FII & FV received FDA 510(k) clearance under submission number K223046, sponsored by Cepheid®. The device was reviewed via the Special premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2023-02-15.
- Submission: K223046
- Applicant / Sponsor: Cepheid®
- Clearance pathway: Special
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7280
- Decision date: 2023-02-15
Classification & Regulation
This clearance is catalogued under FDA product code NPR and 21 CFR 864.7280, within the Hematology review panel as a Class II device.