510(k) K070804
- Device
- VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
- Applicant
- NANOSPHERE, INC
- 510(k) number
- K070804
- Product code
- ODW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-09-17
- Date received
- 2007-03-23
- Regulation
- 862.3360
- Classification name
- Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUE KENT
- Address
- 4088 Commercial Ave. Northbrook IL US 60062 60062
FDA Registration Numbers#
- 3005406097
Source Documents#
Other 510(k) Records For Product Code ODW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183530 | TruDiagnosis System | Akonni Biosystems, Inc. | 2019-05-24 |
| K152612 | eSensor Warfarin Sensitivity Saliva Test | Genmark Diagnostics, Incorporated | 2016-05-26 |
| K073071 | EQ-PRC LC WARFARIN GENOTYPING KIT | Trimgen Corporation | 2009-02-06 |
| K073720 | ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT | Osmetech Molecular Diagnostics | 2008-07-17 |
| K073014 | INFINITI 2C9 & VKORC1 MULTIPLEX ASSAY FOR WARFARIN | Autogenomics, Incorporated | 2008-01-23 |
Legacy Summary#
summary
FDA Review#
Decision Summary