510(k) K223046
- Device
- Xpert® FII & FV
- Applicant
- Cepheid®
- 510(k) number
- K223046
- Product code
- NPR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-15
- Date received
- 2022-09-29
- Regulation
- 864.7280
- Classification name
- Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Suzette Chance
- Address
- 904 Caribbean Dr. Sunnyvale CA US 94089 94089
FDA Registration Numbers#
- 3005406097
- 3016838963
- 3004530258
- 2243471
Source Documents#
Other 510(k) Records For Product Code NPR#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250218 | Xpert® FII & FV | Cepheid | 2025-02-21 |
| K172913 | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | 2018-01-12 |
| K100943 | INVADER FACTOR II | Hologic, Inc. | 2011-06-02 |
| K033612 | FACTOR II (PROTHROMBIN) G20210A KIT | Roche Diagnostics Corp. | 2003-12-18 |