PAT PLATELET AGGREGATION TEST
Device Facts
| Record ID | K881829 |
|---|---|
| Device Name | PAT PLATELET AGGREGATION TEST |
| Applicant | Streck Laboratories, Inc. |
| Product Code | JBX · Hematology |
| Decision Date | Jul 1, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6675 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A platelet aggregometer 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.