510(k) K152579 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
FilmArray Respiratory Panel EZ (RP EZ)
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 3, 2016 |
| Received | Sep 10, 2015 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K152579
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.