|
Device | VENTANA MMR RxDx Panel (Endometrial Cancer with dMMR status) |
Generic Name | Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay |
Regulation Number | 864.1860 |
Applicant | Ventana Medical Systems 1910 E Innovation Park Drive Tucson, AZ 85755 |
PMA Number | P200019 |
Supplement Number | S003 |
Date Received | 01/28/2022 |
Decision Date | 06/10/2022 |
Product Code |
QNH |
Advisory Committee |
Pathology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of two new contract manufacturers as approved suppliers for component parts. |