VENTANA MET (SP44) RxDx Assay
FDA premarket approval P240037/S002 · decided 2025-06-20
Approval details
- PMA number
- P240037
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTANA MET (SP44) RxDx Assay
- Generic name
- Immunohistochemistry Assay, Antibody, MET
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- Date received
- 2025-05-21
- Decision date
- 2025-06-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- SER
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- qualification of an alternate supplier for assay kit component
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