510(k) Report

Devices descending from K031824

4 later devices reach Cobas Integra Cholesterol Gen. 2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings20180—
+1K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS20140—
+1K130200Piccolo Total Cholesterol - Capillary Test SystemAbaxis, Inc.20130—
+1K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—