VERIFYNOW-P2Y12 ASSAY
FDA 510(k) clearance K051231 · decided 2005-08-05
Clearance details
- K-number
- K051231
- Device name
- VERIFYNOW-P2Y12 ASSAY
- Applicant
- Accumetrics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-05-13
- Decision date
- 2005-08-05
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- JOZ
- Device class
- 2
- Regulation number
- 864.5700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VerifyNow P2Y12 Assay, Part Number: 85064, All reagent lots. Product Usage: The VerifyNow recall (Z-1853-2012) | Accumetrics Inc | 2012-06-21 |
| VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whol recall (Z-1854-2012) | Accumetrics Inc | 2012-06-21 |
| VerifyNow P2Y12 Assay Device Kit, Part Number 85054 recall (Z-0228-2007) | Accumetrics Inc | 2006-12-06 |