510(k) K163652 ยท NSU Instrumentation For Clinical Multiplex Test Systems
ePlex Instrument
| Applicant | Genmark Diagnostics, Incorporated, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 9, 2017 |
| Received | Dec 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163652
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.