ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
FDA 510(k) clearance K012701 · decided 2002-06-12
Clearance details
- K-number
- K012701
- Device name
- ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
- Applicant
- Accumetrics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-08-14
- Decision date
- 2002-06-12
- Days to decision
- 302 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 Asprin Assay Kit Part No. 85034 recall (Z-1018-04) | Accumetrics Inc | 2004-07-20 |