510(k) K182619 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
| Applicant | Genmark Diagnostics, Incorporated, Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 12, 2019 |
| Received | Sep 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182619
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.