510(k) Report

Devices descending from K981163

2 later devices reach Diamedix IS-CMV Igg Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131605Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayRoche Diagnostics20141—
+2K220911Elecsys CMV IgGRoche Diagnostics20220—