COLLAGEN REAGENT CAT. NO. 5368
Device Facts
| Record ID | K910706 |
|---|---|
| Device Name | COLLAGEN REAGENT CAT. NO. 5368 |
| Applicant | Helena Laboratories |
| Product Code | GHR · Hematology |
| Decision Date | May 20, 1991 |
| 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.
