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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 10, 2021 | K212176 | CINtec Histology Ventana Medical Systems, Inc. | PRB |
| Mar 4, 2017 | DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) Ventana Medical Systems, Inc. | PRB |
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