← Product Code [SHF](/productcode/SHF) · P250031

# VENTANA PTEN (SP218) RxDx Assay (P250031)

_Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · SHF · Jun 12, 2026 · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P250031

## Device Facts

- **Applicant:** Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- **Product Code:** [SHF](/productcode/SHF.md)
- **Decision Date:** Jun 12, 2026
- **Decision:** APPR

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**Source:** [https://fda.innolitics.com/device/P250031](https://fda.innolitics.com/device/P250031)

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