|
Device | PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL 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 | S008 |
Date Received | 05/06/2013 |
Decision Date | 07/25/2013 |
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 MINOR MODIFICATIONS TO THE DESIGN OF THE DISPENSER INWHICH THE PMA REAGENTS IN THE DEVICES ARE STORED AND OR USED, INCLUDING A CHANGE IN THE MATERIALS THE VARIOUS DISPENSER PARTS ARE MADE FROM. |