510(k) K192150 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
AMICUS Separator System
| Applicant | Fresenius Kabi AG, Bad Homburg, DE |
| Decision | Substantially Equivalent, Nov 13, 2019 |
| Received | Aug 9, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192150
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.