|
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 | S005 |
Date Received | 12/11/2012 |
Decision Date | 03/20/2013 |
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 A CHANGE FROM FLUORINATED BOTTLES TO NON-FLUORINATED BOTTLES FOR STORAGE OF THE AQUEOUS GENERAL PURPOSE REAGENTS USED IN THE STAINING WITH THE PATHWAY ANTI-C-KIT (9.7) RABBIT MONOCLONAL PRIMARY ANTIBODY. |