510(k) Report

Devices descending from DEN170030

3 later devices reach VENTANA anti-MLH-1(M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213348BOND MMR Antibody PanelLeica Biosystems Newcastle, Ltd.20230—
+1K200129OncoMate MSI Dx Analysis SystemPromega Corporation20211—
+2K211181Idylla MSI TestBiocartis NV20230—