510(k) K263054 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, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Sep 22, 2026 |
| Received | Sep 1, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K263054
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.