VENTANA MMR RxDx Panel
FDA premarket approval P210001/S014 · decided 2025-04-17
Approval details
- PMA number
- P210001
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTANA MMR RxDx Panel
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- Date received
- 2025-03-19
- Decision date
- 2025-04-17
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- approval manufacturing process improvement changes to incoming material specifications
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