510(k) K182690 ยท PEO Fungal Organisms, Nucleic Acid-Based Assay
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
| Applicant | Genmark Diagnostics, Incorporated, Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 21, 2018 |
| Received | Sep 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182690
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.