510(k) Report

Devices descending from K092322

2 later devices reach Elecsys Rubella Igm Immunoassay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics20141—
+2K163569Elecsys CMV IgMRoche Diagnostics201702