510(k) Report

Devices descending from K020724

8 later devices reach Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.20240—
+1K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience20084—
+1K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.200617
+2K210801AXINON® LDL-p Test SystemNumares AG20230—
+2K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502
+2K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc.20112—
+3K113830Vantera Clinical AnalyzerLiposcience20121—
+4K133849Vantera Clinical AnalyzerLiposcience20140—