Cervical Intraepithelial Neoplasia (Cin) Test System
Regulation 864.1865
0510(k)s in 12 months (2 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in PRB
| Company | 510(k)s | Recalls |
|---|---|---|
| Ventana Medical Systems, Inc. | 2 | 3 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2018 | Ventana Medical Systems Inc CINtec p16 Histology (250) CE, Catalog Number 06695256001, model 825-4713
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PRB | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PRB | None listed |
| Sep 14, 2018 | Ventana Medical Systems Inc CINtec Histology (250), Catalog Number 06680011001, model 725-4793
Immunohistochemistry (IHC) for in vitro diagnostic use. Terminated |
PRB | None listed |
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