510(k) DEN150013 ยท PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
FilmArray Meningitis/Encephalitis(ME) Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Unknown, Oct 8, 2015 |
| Received | Apr 9, 2015 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN150013
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.