510(k) Report

Devices descending from K960377

1 later device reach Ena-C-T Total 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—