Xpert® FII & FV
FDA 510(k) clearance K223046 · decided 2023-02-15
Clearance details
- K-number
- K223046
- Device name
- Xpert® FII & FV
- Applicant
- Cepheid®
- Decision
- Substantially Equivalent
- Date received
- 2022-09-29
- Decision date
- 2023-02-15
- Days to decision
- 139 days
- Clearance type
- Special
- Product code
- NPR
- Device class
- 2
- Regulation number
- 864.7280
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| Xpert® FII & FV (K250218) | Cepheid | 2025-02-21 |
| cobas Factor II and Factor V Test (K172913) | Roche Molecular Systems, Inc. | 2018-01-12 |
| INVADER FACTOR II (K100943) | Hologic, Inc. | 2011-06-02 |
| FACTOR II (PROTHROMBIN) G20210A KIT (K033612) | Roche Diagnostics Corp. | 2003-12-18 |
Recalls involving this device
No recalls on record reference this clearance.