Panels › Hematology › Product code NPQ · Class 2
Test, Factor V Leiden Mutations, Genomic Dna Pcr
Regulation 864.7280
0510(k)s in 12 months (6 all time)
0recalls in 12 months (14 all time)
3recalls that name a 510(k)
Top companies in NPQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostics Corp. | 1 | 9 |
| Synthes Spine | 0 | 2 |
| AutoGenomics, Inc. | 1 | 0 |
| Cepheid | 1 | 0 |
| Hologic, Inc. | 1 | 0 |
| Illumina, Inc. | 1 | 0 |
| Osmetech Molecular Diagnostics | 1 | 0 |
| Roche Diagnostics Operations, Inc. | 0 | 1 |
| Roche Molecular Systems, Inc. | 0 | 1 |
| Zimmer, Inc. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 1, 2011 | K100980 | INVADER FACTOR V Hologic, Inc. | NPQ |
| Apr 28, 2010 | K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II Illumina, Inc. | NPQ |
| Apr 22, 2010 | K093974 | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING Osmetech Molecular Diagnostics | NPQ |
| Sep 18, 2009 | K082118 | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY Cepheid | NPQ |
| Feb 7, 2007 | K060564 | INFINITI SYSTEM AutoGenomics, Inc. | NPQ |
| Dec 17, 2003 | DEN030005 | FACTOR V LEIDEN KIT Roche Diagnostics Corp. | NPQ |
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