Xpert Hemorrhagic Fever
FDA 510(k) clearance K253653 · decided 2026-02-20
Clearance details
- K-number
- K253653
- Device name
- Xpert Hemorrhagic Fever
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2025-11-20
- Decision date
- 2026-02-20
- Days to decision
- 92 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.