PMA P020055S011

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S011
Product code: NKF
Decision date: 2013-11-15
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: AUTOMATION OF TESTING PROCESSES (CURRENTLY PERFORMED SEMI-MANUALLY) USING THE NEW AUTOMATED DISPENSER VERIFICATION MODULE (DVM).

Current openFDA PMA Record#

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S011
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2013-11-15
Decision code: OK30
Date received: 2013-10-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: AUTOMATION OF TESTING PROCESSES (CURRENTLY PERFORMED SEMI-MANUALLY) USING THE NEW AUTOMATED DISPENSER VERIFICATION MODULE (DVM).