510(k) K262136 ยท PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
BIOFIRE SPOTFIRE Vaginitis (VG) Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 21, 2026 |
| Received | Jun 25, 2026 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K262136
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.