510(k) K101196 ยท FPA Set, Administration, Intravascular
ACCU-CHEK ULTRFLEX INFUSION SET
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 27, 2010 |
| Received | Apr 29, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101196
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.