510(k) Report

Devices descending from K801834

2 later devices reach Wako HDL Cholesterol Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063852Accessa Cholesterol PanelHome Access Health Corp.20070—
+1K963847Wako Direct HDL-CWako Chemicals USA, Inc.19960—