510(k) K002885 ยท JOZ System, Automated Platelet Aggregation
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
| Applicant | Dade Behring, Inc., P.O. Box 6101, Newark DE, US |
| Decision | Substantially Equivalent, Jun 21, 2001 |
| Received | Sep 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002885
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.