510(k) Report

Devices descending from K974613

3 later devices reach Virotrol Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060770Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and ControlsOrtho-Clinical Diagnostics, Inc.20061—
+1K032993Vitros Immunodiagnostic Products Anti-HBC Igm ControlsOrtho-Clinical Diagnostics, Inc.200301
+2K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc.20160—