510(k) K163053 ยท JIT Calibrator, Secondary
Lumipulse G E2-III Calibrators
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Dec 1, 2016 |
| Received | Nov 1, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K163053
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.