|
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 | S030 |
Date Received | 10/26/2023 |
Decision Date | 11/08/2023 |
Product Code |
NKF |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement addition of an alternative supplier for dispenser component parts |