PMA P020055S008

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S008
Product code: NKF
Decision date: 2013-07-25
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE DISPENSER INWHICH THE PMA REAGENTS IN THE DEVICES ARE STORED AND OR USED, INCLUDING A CHANGE IN THE MATERIALS THE VARIOUS DISPENSER PARTS ARE MADE FROM.

Current openFDA PMA Record#

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S008
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2013-07-25
Decision code: APPR
Date received: 2013-05-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MINOR MODIFICATIONS TO THE DESIGN OF THE DISPENSER INWHICH THE PMA REAGENTS IN THE DEVICES ARE STORED AND OR USED, INCLUDING A CHANGE IN THE MATERIALS THE VARIOUS DISPENSER PARTS ARE MADE FROM.