|
Device | VENTANA ALK (D5F3) CDx Assay |
Generic Name | Immunohistochemistry assay, antibody, anaplastic lymphoma kinase |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 EAST INNOVATION PARK DR. TUCSON, AZ 85755 |
PMA Number | P140025 |
Supplement Number | S009 |
Date Received | 06/18/2018 |
Decision Date | 09/13/2018 |
Product Code |
PKW |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for implementing a BenchMark Scanners software supplement for Ventana Systems Software (VSS) 12.3 on the BenchMark ULTRA Instrument. |