510(k) Report

Devices descending from K063841

4 later devices reach NMR Profiler and NMR Lipoprofile Assay, Controls through their predicates, nearest generation first.

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