VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
FDA 510(k) clearance K070804 · decided 2007-09-17
Clearance details
- K-number
- K070804
- Device name
- VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TEST
- Applicant
- Nanosphere, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-23
- Decision date
- 2007-09-17
- Days to decision
- 178 days
- Clearance type
- Traditional
- Product code
- ODW
- Device class
- 2
- Regulation number
- 862.3360
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Warfarin Metabolism Nucleic Acid Test Cartridge; Part Number: 20-006-002; an in vitro diag recall (Z-1383-2008) | Nanosphere, Inc. | 2008-03-31 |