PMA P210001S005

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S005
Product code: QNH
Decision date: 2022-05-20
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Approval order statement: Approval of the clinical protocol entitled Statistical Analysis Plan for MK-3475 dMMR VENTANA MMR RxDx Panel Post Approval Analysis.

Current openFDA PMA Record#

Device: VENTANA MMR RxDx Panel
Applicant: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
PMA number: P210001
Supplement: S005
Product code: QNH
Generic name: Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
Decision date: 2022-05-20
Decision code: APPR
Date received: 2022-04-28
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the clinical protocol entitled Statistical Analysis Plan for MK-3475 dMMR VENTANA MMR RxDx Panel Post Approval Analysis.