|
Device | PATHWAY Anti-c-KIT (9.7) Primary Antibody |
Generic Name | Immunohistochemistry antibody assay, c-kit |
Regulation Number | 864.1860 |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P020055 |
Supplement Number | S023 |
Date Received | 08/26/2020 |
Decision Date | 11/13/2020 |
Product Code |
NKF |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for replacement of dispenser molds used in the injection molding process for six (6) dispenser parts. |