Xpert Hemorrhagic Fever— 510(k) K253653
Substantially EquivalentCepheid
FDA 510(k) clearance K253653 for Xpert Hemorrhagic Fever, Substantially Equivalent on 2026-02-20. Applicant: Cepheid.
Summary
Cepheid's Xpert Hemorrhagic Fever has no product code in the record, so there's no code name either. The record doesn't describe the device beyond its name.
The record gives no device class or regulation number. The classification panel is listed as Unknown, and the Microbiology review panel handled it as a Traditional 510(k).
Cepheid filed from Sunnyvale, California. Review took 92 calendar days (November 20, 2025 to February 20, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Cepheid
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
More clearances from Cepheid
view allData sourced from openFDA. This site is unofficial and independent of the FDA.