510(k) Report

Devices descending from K033610

2 later devices reach HDL-Cholesterol Plus 2ND Generation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120662Piccolo HDL-Capillary Test SystemAbaxis, Inc.20120—
+1K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—