FDA Product Code
FDA Product Code NPR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7280
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K250218 | Xpert® FII & FV | Cepheid | 2025-02-21 | Special | PDF ↗ |
| K223046 | Xpert® FII & FV | Cepheid® | 2023-02-15 | Special | PDF ↗ |
| K172913 | cobas Factor II and Factor V Test | Roche Molecular Systems, Inc. | 2018-01-12 | Traditional | PDF ↗ |
| K100943 | INVADER FACTOR II | Hologic, Inc. | 2011-06-02 | Traditional | PDF ↗ |
| K033612 | FACTOR II (PROTHROMBIN) G20210A KIT | Roche Diagnostics Corp. | 2003-12-18 | Traditional | PDF ↗ |
Product code NPR · Class II · Hematology. Data: openFDA.