510(k) Report

Devices descending from K030067

1 later device reach Vitros Immunodiagnostic Products Hbsag Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150815BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge KitBecton, Dickinson and Company201501