510(k) Report

Devices descending from K060854

3 later devices reach Abx Pentra 400: Lipoproteins through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110—
+1K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+1K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—