DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
Device Facts
| Record ID | K002885 |
|---|---|
| Device Name | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP |
| Applicant | Dade Behring, Inc. |
| Product Code | JOZ · Hematology |
| Decision Date | Jun 21, 2001 |
| 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.
