PLATELET AGGREGATION REAGENT
Device Facts
| Record ID | K850592 |
|---|---|
| Device Name | PLATELET AGGREGATION REAGENT |
| Applicant | Chrono-Log Corp. |
| Product Code | JBX · Hematology |
| Decision Date | May 13, 1985 |
| 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.
