|
Device | VENTANA MMR RxDx Panel Solid Tumors with dMMR status) |
Generic Name | Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay |
Regulation Number | 864.1860 |
Applicant | Ventana Medical Systems Inc (Roche Tissue Diagnostics) 1910 E. Innovation Park Drive Tucson, AZ 85755 |
PMA Number | P210001 |
Supplement Number | S009 |
Date Received | 08/01/2023 |
Decision Date | 08/29/2023 |
Product Code |
QNH |
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 Addition of two contract manufacturers as approved suppliers of parts/components. |