510(k) K232954 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 26, 2024 |
| Received | Sep 21, 2023 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K232954
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2026 | BioFire Diagnostics, LLC Biofire Spotfire Respiratory/Sore Throat Panel
REF: 423485 Open, Classified |
QOF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.