510(k) K130515 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
VIRTUOSO SYSTEM FOR IHC ER (SPI)
| Applicant | Ventana Medical Systems, Inc., Los Angeles CA, US |
| Decision | Substantially Equivalent, Nov 22, 2013 |
| Received | Feb 27, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130515
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.