510(k) K243544 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Aug 14, 2025 |
| Received | Nov 15, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K243544
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.