PMA P140025S023

Device: VENTANA ALK (D5F3) CDx Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P140025
Supplement: S023
Product code: PKW
Decision date: 2024-01-26
Classification: Pathology
Generic name: Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).

Current openFDA PMA Record#

Device: VENTANA ALK (D5F3) CDx Assay
Applicant: Ventana Medical Systems, Inc.
PMA number: P140025
Supplement: S023
Product code: PKW
Generic name: Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
Decision date: 2024-01-26
Decision code: APPR
Date received: 2023-10-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for a change in expiry dating (extension to the stability from 12 months to 18 months) for Hematoxylin (PN 760-2021) and Hematoxylin II (PN 790-2208).