PMA P210026
- Device
- Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P210026
- Product code
- QQT
- Decision date
- 2026-09-11
- Generic name
- Immunohistochemistry assay, antibody, Ki-67
- Approval order statement
- approval of manufacturing process and equipment changes for filling and capping
Current openFDA PMA Record#
- Device
- Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
- Applicant
- Agilent Technologies, Inc.
- PMA number
- P210026
- Supplement
- S003
- Product code
- QQT
- Generic name
- Immunohistochemistry assay, antibody, Ki-67
- Decision date
- 2026-09-11
- Decision code
- OK30
- Date received
- 2026-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval of manufacturing process and equipment changes for filling and capping