510(k) K230719 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 13, 2023 |
| Received | Mar 15, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230719
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.