PACKS-4 (TM) ANALYZER
Device Facts
| Record ID | K912201 |
|---|---|
| Device Name | PACKS-4 (TM) ANALYZER |
| Applicant | Helena Laboratories |
| Product Code | JBY · Hematology |
| Decision Date | Aug 16, 1991 |
| 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.
