ADP REAGENT, MODIFIED
Device Facts
| Record ID | K952252 |
|---|---|
| Device Name | ADP REAGENT, MODIFIED |
| Applicant | Helena Laboratories |
| Product Code | GHR · Hematology |
| Decision Date | Sep 8, 1995 |
| 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.
