510(k) K180486 ยท GJT Plasma, Coagulation Factor Deficient
HemosIL Factor XII Deficient Plasma
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Mar 22, 2018 |
| Received | Feb 23, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180486
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.