K253653 is an FDA 510(k) clearance for the Xpert Hemorrhagic Fever..
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on February 20, 2026, 92 days after receiving the submission on November 20, 2025.
This device falls under the Microbiology FDA review panel.
| 510(k) Number | K253653 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2025 |
| Decision Date | February 20, 2026 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | — |
| Device Class | — |