Clearance Summary
Xpert Xpress CoV-2/Flu/RSV plus received FDA 510(k) clearance under submission number K231481, sponsored by Cepheid®. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2023-08-17.
- Submission: K231481
- Applicant / Sponsor: Cepheid®
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3981
- Decision date: 2023-08-17
Classification & Regulation
This clearance is catalogued under FDA product code QOF and 21 CFR 866.3981, within the Microbiology review panel as a Class II device.