PMA P020055S014

Device
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant
Ventana Medical Systems, Inc.
PMA number
P020055
Supplement
S014
Product code
NKF
Decision date
2014-05-06
Generic name
Immunohistochemistry antibody assay, c-kit
Approval order statement
APPROVAL FOR A NEW ADHESIVE FOR THE SLIDE HEATERS ON THE BENCHMARK XT AND ULTRA AUTOMATED SLIDE STAINERS.

Current openFDA PMA Record#

Device
PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY
Applicant
Ventana Medical Systems, Inc.
PMA number
P020055
Supplement
S014
Product code
NKF
Generic name
Immunohistochemistry antibody assay, c-kit
Decision date
2014-05-06
Decision code
APPR
Date received
2014-02-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A NEW ADHESIVE FOR THE SLIDE HEATERS ON THE BENCHMARK XT AND ULTRA AUTOMATED SLIDE STAINERS.