510(k) Report

Devices descending from K952127

5 later devices reach Boehringer Mannheim Cholesterol Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031824Cobas Integra Cholesterol Gen. 2Roche Diagnostics Corp.200341
+2K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings20180—
+2K132031Afinion Lipid Panel and Afinion Lipid Panel ControlAxis-Shield Poc AS20140—
+2K130200Piccolo Total Cholesterol - Capillary Test SystemAbaxis, Inc.20130—
+2K111753Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and…Hitachi Chemical Diagnostics, Inc.20110—