510(k) K060564
- Device
- INFINITI SYSTEM
- Applicant
- AUTOGENOMICS, INC
- 510(k) number
- K060564
- Product code
- NPQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-07
- Date received
- 2006-03-03
- Regulation
- 864.7280
- Classification name
- Test, Factor V Leiden Mutations, Genomic Dna Pcr
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EVELYN LOPEZ
- Address
- 2251 Rutherford Rd. Carlsbad CA US 92008 92008
FDA Registration Numbers#
- 3016838963
- 3004530258
- 2243471
- 3005406097
Source Documents#
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 |
| DEN030005 | FACTOR V LEIDEN KIT | Roche Diagnostics Corp. | 2003-12-17 |
Legacy Summary#
summary
FDA Review#
Decision Summary