510(k) K243759 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 20, 2024 |
| Received | Dec 6, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243759
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.