510(k) Report

Devices descending from K984180

6 later devices reach The Aptus (Automated) Application of the Rubella Igm Elisa Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092322Elecsys Rubella Igm ImmunoassayRoche Diagnostics20102—
+1K072617Elecsys Rubella Igg ImmunoassayRoche Diagnostics Corp.20082—
+2K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics20141—
+2K131605Elecsys Precicontrol CMV Igg, Elecsys CMV Igg ImmunoassayRoche Diagnostics20141—
+3K220911Elecsys CMV IgGRoche Diagnostics20220—
+3K163569Elecsys CMV IgMRoche Diagnostics201702