GKW · Aggregometer, Platelet, Thrombokinetogram
Hematology · 21 CFR 864.6675 · Class 2
Overview
| Product Code | GKW |
|---|---|
| Device Name | Aggregometer, Platelet, Thrombokinetogram |
| Regulation | 21 CFR 864.6675 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
