510(k) K213236 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 27, 2022 |
| Received | Sep 30, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213236
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.