PMA P210026S002

Device: Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Applicant: Agilent Technologies, Inc.
PMA number: P210026
Supplement: S002
Product code: QQT
Decision date: 2025-02-28
Classification: Pathology
Generic name: Immunohistochemistry assay, antibody, Ki-67
Approval order statement: Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.

Current openFDA PMA Record#

Device: Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Applicant: Agilent Technologies, Inc.
PMA number: P210026
Supplement: S002
Product code: QQT
Generic name: Immunohistochemistry assay, antibody, Ki-67
Decision date: 2025-02-28
Decision code: APPR
Date received: 2025-01-31
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.