PMA P230016S001

Device: MAGE-A4 IHC 1F9 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P230016
Supplement: S001
Product code: SBL
Decision date: 2025-02-28
Classification: Pathology
Generic name: Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
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: MAGE-A4 IHC 1F9 pharmDx
Applicant: Agilent Technologies, Inc.
PMA number: P230016
Supplement: S001
Product code: SBL
Generic name: Immunohistochemistry Assay, Antibody, Melanoma-associated antigen A4
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.