510(k) DEN030005
- Device
- FACTOR V LEIDEN KIT
- Applicant
- Roche Diagnostics Corp.
- 510(k) number
- DEN030005
- Product code
- NPQ
- Decision
- Unknown (DENG)
- Decision date
- 2003-12-17
- Date received
- 2003-12-08
- Regulation
- 864.7280
- Classification name
- Test, Factor V Leiden Mutations, Genomic Dna Pcr
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROBERT A GREGG
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3016838963
- 3004530258
- 2243471
- 3005406097
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code NPQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100980 | INVADER FACTOR V | Hologic, Inc. | 2011-06-01 |
| K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II | Illumina, Inc. | 2010-04-28 |
| K093974 | ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING | Osmetech Molecular Diagnostics | 2010-04-22 |
| K082118 | XPERT HEMOSIL FACTOR II & FACTOR V ASSAY | Cepheid | 2009-09-18 |
| K060564 | INFINITI SYSTEM | AutoGenomics, Inc. | 2007-02-07 |