PMA P140025S002

Device: VENTANA ALK (D5F3) CDX ASSAY
Applicant: Ventana Medical Systems, Inc.
PMA number: P140025
Supplement: S002
Product code: PKW
Decision date: 2016-04-13
Classification: Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase
Generic name: Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
Approval order statement: Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.

Current openFDA PMA Record#

Device: VENTANA ALK (D5F3) CDX ASSAY
Applicant: Ventana Medical Systems, Inc.
PMA number: P140025
Supplement: S002
Product code: PKW
Generic name: Immunohistochemistry assay, antibody, anaplastic lymphoma kinase
Decision date: 2016-04-13
Decision code: APPR
Date received: 2015-12-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the following:1) Enlargement of a bulk formulation room at Ventana Medical Systems' Tucson, AZ facility; and 2) addition of two large volume tanks, along with supply plumbing, a clean in place (CIP) procedure, and new filler, as well as a new fill line.