510(k) DEN160019 ยท PRB Cervical Intraepithelial Neoplasia (Cin) Test System
CINtec Histology (50 tests), CINtec Histology (250 tests)
| Applicant | Ventana Medical Systems, Inc., Tucson AZ, US |
| Decision | Unknown, Mar 4, 2017 |
| Received | May 23, 2016 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN160019
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.