510(k) K140619 ยท MYI System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
MECA XPRESSFISH
| Applicant | Advandx, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Oct 10, 2014 |
| Received | Mar 11, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140619
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.