510(k) Report

Devices descending from K982341

3 later devices reach Direct HDL-Cholestrol Liquid through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.20160—
+1K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS20140—
+1K031924Vitros 5,1 FS Chemistry System, Vitros Chemistry Products DHDL Reagent Pack, Calibrator…Ortho-Clinical Diagnostics2003029