510(k) K163546 ยท JIT Calibrator, Secondary
Lumipulse G Progesterone-N Calibrators
| Applicant | Fujirebio Diagnostics,Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jan 13, 2017 |
| Received | Dec 16, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K163546
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.