|
Device | VENTANA PATHWAY ANTI-C-KIT PRIMARY ANTIBODY (POLYCLONAL) |
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 | S017 |
Date Received | 08/26/2015 |
Decision Date | 09/24/2015 |
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 CHANGE FROM MANUAL KITTING TO AUTOMATED KITTING OF THE REAGENT DISPENSERS. |