510(k) K140465 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER
| Applicant | Ventana Medical Systems, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Mar 20, 2014 |
| Received | Feb 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 23, 2020 | Roche Molecular Systems, Inc. uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001 Terminated |
NQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.