FDA Product Code
FDA Product Code NPQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7280
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100980 | INVADER FACTOR V | Hologic, Inc. | 2011-06-01 | Traditional | PDF ↗ |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | Illumina, Inc. | 2010-04-28 | Traditional | PDF ↗ |
| K093974 | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING | Osmetech Molecular Diagnostics | 2010-04-22 | Traditional | PDF ↗ |
| K082118 | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY | Cepheid | 2009-09-18 | Traditional | PDF ↗ |
| K060564 | INFINITI SYSTEM | AutoGenomics, Inc. | 2007-02-07 | Traditional | PDF ↗ |
| DEN030005 | FACTOR V LEIDEN KIT | Roche Diagnostics Corp. | 2003-12-17 | Post-NSE | — |
Product code NPQ · Class II · Hematology. Data: openFDA.