510(k) K123620 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
FILMARRAY RESPIRATORY PANEL (RP)
| Applicant | Biofire Diagnostics, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Feb 11, 2013 |
| Received | Nov 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123620
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.