PMA P220006S004
- Device
- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P220006
- Supplement
- S004
- Product code
- QUL
- Decision date
- 2023-11-08
- Classification
- Medical Genetics
- Generic name
- Immunohistochemistry Assay, Antibody, FOLR1
- Approval order statement
- addition of an alternative supplier for dispenser component parts
Current openFDA PMA Record#
- Device
- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P220006
- Supplement
- S004
- Product code
- QUL
- Generic name
- Immunohistochemistry Assay, Antibody, FOLR1
- Decision date
- 2023-11-08
- Decision code
- OK30
- Date received
- 2023-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternative supplier for dispenser component parts