FDA Product Code
FDA Product Code PRB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Pathology
- 21 CFR Citation
- 864.1865
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K212176 | CINtec Histology | Ventana Medical Systems, Inc. | 2021-12-10 | Traditional | PDF ↗ |
| DEN160019 | CINtec Histology (50 tests), CINtec Histology (250 tests) | Ventana Medical Systems, Inc. | 2017-03-04 | Direct | — |
Product code PRB · Class II · Pathology. Data: openFDA.