510(k) K121033 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
| Applicant | Ventana Medical Systems, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 6, 2013 |
| Received | Apr 5, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121033
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.