PMA P020055S015

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S015
Product code: NKF
Decision date: 2015-02-19
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS.

Current openFDA PMA Record#

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S015
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2015-02-19
Decision code: APPR
Date received: 2014-06-16
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS.