510(k) K160462 ยท PLO Meningitis/Encephalitis Pathogen Multiplex Nucleic Acid Detection System
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 17, 2016 |
| Received | Feb 19, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160462
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.