|
Device | PATHWAY ANTI-C-KIT (9.7) RABBITT MONOCLONAL PRIMARY ANTOBODY |
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 | S010 |
Date Received | 10/11/2013 |
Decision Date | 06/13/2014 |
Product Code |
NKF |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR ADDITION OF A NEW SUPPLIER FOR PRODUCTION OF THE BULK RAW MATERIAL AND FOR A DESIGN CHANGE WHERE THE UNPURIFIED CELL CULTURE MEDIUM DILUTING THE BULK RAW MATERIAL WILL SWITCH FROM AN RPMI-BASED SOLUTION TO AN E-RDF 5-BASED SOLUTION. |