PLATELET AGGREGATION PROFILER #PAP-4
Device Facts
| Record ID | K821005 |
|---|---|
| Device Name | PLATELET AGGREGATION PROFILER #PAP-4 |
| Applicant | Bio/Data Corp. |
| Product Code | JBX · Hematology |
| Decision Date | Jun 1, 1982 |
| 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.
