PMA P020055S006

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S006
Product code: NKF
Decision date: 2013-04-02
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: ADD AN ALTERNATE QUALIFIED SUPPLIER FOR SUBASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS, CRITICAL COMPONENTSUSED IN THE MANUFACTURE OF THE SUBJECT REAGENTS.

Current openFDA PMA Record#

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S006
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2013-04-02
Decision code: OK30
Date received: 2013-03-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADD AN ALTERNATE QUALIFIED SUPPLIER FOR SUBASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS, CRITICAL COMPONENTSUSED IN THE MANUFACTURE OF THE SUBJECT REAGENTS.