|
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 | S026 |
Date Received | 02/16/2022 |
Decision Date | 07/21/2022 |
Product Code |
NKF |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for (i) a change in expiry dating from Hematoxylin and Hematoxylin II and (ii) implementation of a revised process for creating reference slides used in Surveillance and Stability testing of Hematoxylin and Hematoxylin II. |