Panels › Hematology › Product code NPR · Class 2
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
Regulation 864.7280
0510(k)s in 12 months (5 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in NPR
| Company | 510(k)s | Recalls |
|---|---|---|
| Cepheid | 2 | 0 |
| Roche Molecular Systems, Inc. | 1 | 1 |
| Hologic, Inc. | 1 | 0 |
| Roche Diagnostics Corp. | 1 | 0 |
| Roche Diagnostics Operations, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 21, 2025 | K250218 | Xpert® FII & FV Cepheid | NPR |
| Feb 15, 2023 | K223046 | Xpert® FII & FV Cepheid® | NPR |
| Jan 12, 2018 | K172913 | cobas Factor II and Factor V Test Roche Molecular Systems, Inc. | NPR |
| Jun 2, 2011 | K100943 | INVADER FACTOR II Hologic, Inc. | NPR |
| Dec 18, 2003 | K033612 | FACTOR II (PROTHROMBIN) G20210A KIT Roche Diagnostics Corp. | NPR |
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