510(k) K261475 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
BIOFIRE® FILMARRAY® Tropical Fever Panel Control Kit
| Applicant | Biofire Defense, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jul 17, 2026 |
| Received | May 5, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261475
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.