PMA P020055S005

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S005
Product code: NKF
Decision date: 2013-03-20
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: APPROVAL FOR A CHANGE FROM FLUORINATED BOTTLES TO NON-FLUORINATED BOTTLES FOR STORAGE OF THE AQUEOUS GENERAL PURPOSE REAGENTS USED IN THE STAINING WITH THE PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY.

Current openFDA PMA Record#

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S005
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2013-03-20
Decision code: APPR
Date received: 2012-12-11
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE FROM FLUORINATED BOTTLES TO NON-FLUORINATED BOTTLES FOR STORAGE OF THE AQUEOUS GENERAL PURPOSE REAGENTS USED IN THE STAINING WITH THE PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY.