RISTOCETIN PLATELET AGGREGA-REAGENT TEST
Device Facts
| Record ID | K832929 |
|---|---|
| Device Name | RISTOCETIN PLATELET AGGREGA-REAGENT TEST |
| Applicant | Sigma Chemical Co. |
| Product Code | JBX · Hematology |
| Decision Date | Sep 29, 1983 |
| 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.
