510(k) K121516 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
| Applicant | Ventana Medical Systems, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Sep 26, 2013 |
| Received | May 22, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121516
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.