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510(k) DEN170030

VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP 93) Mouse Monoclonal Primary Antibody, VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody by Ventana Medical Systems — Product Code PZJ

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
October 27, 2017
Date Received
May 30, 2017
Clearance Type
Direct
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

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