510(k) K143446 ยท FPA Set, Administration, Intravascular
Accu-Chek FlexLink Plus infusion set
| Applicant | Roche Diagnostics GmbH, Mannheim, DE |
| Decision | Substantially Equivalent, Aug 13, 2015 |
| Received | Dec 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143446
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.