510(k) Report

Devices descending from K971162

5 later devices reach Liquid N-Geneous HDL Cholesterol Kit/Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience20084—
+2K210801AXINON® LDL-p Test SystemNumares AG20230—
+2K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc.20112—
+3K113830Vantera Clinical AnalyzerLiposcience20121—
+4K133849Vantera Clinical AnalyzerLiposcience20140—