510(k) K243013 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
LIAISON PLEX Gram-Negative Blood Culture Assay
| Applicant | Luminex Corporation, Northbrook IL, US |
| Decision | Substantially Equivalent, Apr 18, 2025 |
| Received | Sep 27, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243013
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.