510(k) Report

Devices descending from K011250

2 later devices reach Vitros Immunodiagnostic Products Hbsag Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030067Vitros Immunodiagnostic Products Hbsag ControlsOrtho-Clinical Diagnostics200311
+2K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitBecton, Dickinson and Company201501