510(k) K143080 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 17, 2015 |
| Received | Oct 27, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143080
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.