510(k) K162462 ยท GKT Separator, Automated, Blood Cell, Diagnostic
AMICUS Separator System, AMICUS Separator System; Refurbished
| Applicant | Fresenius Kabi USA,Llc, Lake Zurich IL, US |
| Decision | Substantially Equivalent, Nov 23, 2016 |
| Received | Sep 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162462
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.