510(k) Report

Devices descending from K983805

3 later devices reach The Aptus (Automated) Application of the Rubella Igg Elisa Test System. an… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072617Elecsys Rubella Igg ImmunoassayRoche Diagnostics Corp.20082—
+2K131605Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayRoche Diagnostics20141—
+3K220911Elecsys CMV IgGRoche Diagnostics20220—