510(k) K181663 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
| Applicant | Genmark Diagnostics, Incorporated, Carlsbad CA, US |
| Decision | Substantially Equivalent, Dec 20, 2018 |
| Received | Jun 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181663
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.