PMA P210001S014
- Device
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P210001
- Supplement
- S014
- Product code
- QNH
- Decision date
- 2025-04-17
- Classification
- Pathology
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Approval order statement
- approval manufacturing process improvement changes to incoming material specifications
Current openFDA PMA Record#
- Device
- VENTANA MMR RxDx Panel
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- PMA number
- P210001
- Supplement
- S014
- Product code
- QNH
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Decision date
- 2025-04-17
- Decision code
- OK30
- Date received
- 2025-03-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval manufacturing process improvement changes to incoming material specifications