Xpert Hemorrhagic Fever
FDA 510(k) clearance K261362 · decided 2026-08-07
Clearance details
- K-number
- K261362
- Device name
- Xpert Hemorrhagic Fever
- Applicant
- Cepheid
- Decision
- Substantially Equivalent
- Date received
- 2026-04-27
- Decision date
- 2026-08-07
- Days to decision
- 102 days
- Clearance type
- Dual Track
- Product code
- QVR
- Device class
- 2
- Regulation number
- 866.4000
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| T2 Biothreat Panel (K231336) | T2biosystems, Inc. | 2023-09-15 |
| BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (K213362) | Biofire Defense, LLC | 2023-03-22 |
Recalls involving this device
No recalls on record reference this clearance.