510(k) K170604 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
FilmArray Respiratory Panel 2 (RP2)
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 30, 2017 |
| Received | Mar 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170604
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.