PMA P020055S010

Device: PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S010
Product code: NKF
Decision date: 2014-06-13
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: APPROVAL FOR ADDITION OF A NEW SUPPLIER FOR PRODUCTION OF THE BULK RAW MATERIAL AND FOR A DESIGN CHANGE WHERE THE UNPURIFIED CELL CULTURE MEDIUM DILUTING THE BULK RAW MATERIAL WILL SWITCH FROM AN RPMI-BASED SOLUTION TO AN E-RDF 5-BASED SOLUTION.

Current openFDA PMA Record#

Device: PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S010
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2014-06-13
Decision code: APPR
Date received: 2013-10-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR ADDITION OF A NEW SUPPLIER FOR PRODUCTION OF THE BULK RAW MATERIAL AND FOR A DESIGN CHANGE WHERE THE UNPURIFIED CELL CULTURE MEDIUM DILUTING THE BULK RAW MATERIAL WILL SWITCH FROM AN RPMI-BASED SOLUTION TO AN E-RDF 5-BASED SOLUTION.