510(k) K211079 ยท QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
BioFire COVID-19 Test 2
| Applicant | Biofire Defense, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 1, 2021 |
| Received | Apr 12, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211079
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.