VENTANA PTEN (SP218) RxDx Assay
Device Facts
| Record ID | P250031 |
|---|---|
| Device Name | VENTANA PTEN (SP218) RxDx Assay |
| Applicant | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
| Product Code | SHF |
| Decision Date | Jun 12, 2026 |
| Decision | APPR |
| Record ID | P250031 |
|---|---|
| Device Name | VENTANA PTEN (SP218) RxDx Assay |
| Applicant | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
| Product Code | SHF |
| Decision Date | Jun 12, 2026 |
| Decision | APPR |
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