MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
FDA 510(k) clearance K013596 · decided 2002-05-16
Clearance details
- K-number
- K013596
- Device name
- MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
- Applicant
- Accumetrics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-10-31
- Decision date
- 2002-05-16
- Days to decision
- 197 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 IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit recall (Z-1172-2014) | Accumetrics Inc | 2014-03-11 |
| VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. Th recall (Z-0482-2014) | Accumetrics Inc | 2013-12-11 |