510(k) K243463 ยท QMV Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
BIOFIRE FILMARRAY Tropical Fever Panel
| Applicant | Biofire Diagnostics, LLC (Biomerieux), Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 5, 2024 |
| Received | Nov 8, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243463
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.