|
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 | S006 |
Date Received | 03/04/2013 |
Decision Date | 04/02/2013 |
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 ADD AN ALTERNATE QUALIFIED SUPPLIER FOR SUBASSEMBLIES USED IN THE PRODUCTION OF THE BENCHMARK ULTRA AND BENCHMARK XT INSTRUMENTS, CRITICAL COMPONENTSUSED IN THE MANUFACTURE OF THE SUBJECT REAGENTS. |