ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
Device Facts
| Record ID | K011337 |
|---|---|
| Device Name | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) |
| Applicant | Accumetrics, Inc. |
| Product Code | JOZ · Hematology |
| Decision Date | Oct 16, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5700 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
