510(k) Report

Devices descending from K000568

5 later devices reach HDL Cholesterol Plus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032932Direct HDL-Cholesterol Liquid Color; Direct HDL/LDL-Cholesterol CalibratorStanbio Laboratory20040—
+1K033610HDL-Cholesterol Plus 2ND GenerationRoche Diagnostics Corp.20032—
+1K014018Cholesterol 1, 2, 3Imi20020—
+2K120662Piccolo HDL-Capillary Test SystemAbaxis, Inc.20120—
+2K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—