510(k) K221460 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, Jul 25, 2022 |
| Received | May 19, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221460
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.