510(k) Report

Devices descending from K905405

3 later devices reach Chemtrak Accumeter Cholesterol Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981181Ena-C-T Total Cholesterol Test Model F 20000, (Physician Directed Use)Actimed Laboratories, Inc.19980—
+1K960377Ena-C-T Total Cholesterol TestActimed Laboratories, Inc.19961—
+1K960378Ena-C-T Assayed Total Cholesterol ControlsActimed Laboratories, Inc.19960—