PMA P240037S001

Device: VENTANA MET (SP44) RxDx Assay
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P240037
Supplement: S001
Product code: SER
Decision date: 2025-07-11
Classification: Pathology
Generic name: Immunohistochemistry Assay, Antibody, MET
Approval order 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.

Current openFDA PMA Record#

Device: VENTANA MET (SP44) RxDx Assay
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P240037
Supplement: S001
Product code: SER
Generic name: Immunohistochemistry Assay, Antibody, MET
Decision date: 2025-07-11
Decision code: APPR
Date received: 2025-06-11
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order 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.