PLATELET AGGREGOMETERS
Device Facts
| Record ID | K820422 |
|---|---|
| Device Name | PLATELET AGGREGOMETERS |
| Applicant | Chrono-Log Corp. |
| Product Code | GHR · Hematology |
| Decision Date | Mar 16, 1982 |
| 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.
