510(k) K131140 ยท OEO Automated Digital Image Manual Interpretation Microscope
OMNYX IDP FOR HER2 MANUAL APPLICATION
| Applicant | Omnyx, LLC, Marlborough MA, US |
| Decision | Substantially Equivalent, Apr 1, 2014 |
| Received | Apr 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131140
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.