VENTANA MET (SP44) RxDx Assay
FDA premarket approval P240037/S001 · decided 2025-07-11
Approval details
- PMA number
- P240037
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- VENTANA MET (SP44) RxDx Assay
- Generic name
- Immunohistochemistry Assay, Antibody, MET
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- Date received
- 2025-06-11
- Decision date
- 2025-07-11
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- SER
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval of the clinical protocol titled Prevalence and Efficacy Assessment for VENTANA MET (SP44) RxDx Assay by the Different Cellular Compartments, for the post-approval study (PAS) protocol.
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