510(k) DEN200031 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
BioFire Respiratory Panel 2.1 (RP2.1)
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Unknown, Mar 17, 2021 |
| Received | May 19, 2020 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN200031
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.