510(k) Report

Devices descending from K081338

4 later devices reach Roche Elecsys Anti-CCP Immunoassay, Roche Elecsys Precicontrol Anti-CCP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121895Elecsys HSV-2 Igg ImmunoassayRoche Diagnostics20121—
+1K120625Elecsys HSV-1 Igg Immunoassay Elecsys Precicontrol HSVRoche Diagnostics20121—
+2K220923Elecsys HSV-1 IgG (08948844160)Roche Diagnostics20220—
+2K220924Elecsys HSV-2 IgG (08948887160)Roche Diagnostics20220—