Home / 510(k) Clearances / K200129

510(k) K200129

OncoMate MSI Dx Analysis System by Promega Corporation — Product Code PZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2021
Date Received
January 21, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lynch Syndrome Test System
Device Class
Class II
Regulation Number
864.1866
Review Panel
PA
Submission Type

The Lynch syndrome test system is used to identify loss of DNA mismatch repair proteins or microsatellite instability in tumor tissue from cancer patients for the purpose of identifying patients who may benefit from additional testing for the inherited cancer predisposition Lynch Syndrome

Other clearances for product code PZJ

  • K211181 — Idylla MSI Test (February 27, 2023)
  • K213348 — BOND MMR Antibody Panel (February 21, 2023)
  • DEN170030 — VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16 (October 27, 2017)