PMA P020055S007

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S007
Product code: NKF
Decision date: 2013-05-13
Generic name: Immunohistochemistry antibody assay, c-kit
Approval order statement: ADDITION OF A NEW SUPPLIER OF PRINTED CIRCUIT BOARD ASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS.

Current openFDA PMA Record#

Device: PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant: Ventana Medical Systems, Inc.
PMA number: P020055
Supplement: S007
Product code: NKF
Generic name: Immunohistochemistry antibody assay, c-kit
Decision date: 2013-05-13
Decision code: OK30
Date received: 2013-04-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITION OF A NEW SUPPLIER OF PRINTED CIRCUIT BOARD ASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS.