510(k) Report

Devices descending from K941573

4 later devices reach Roche Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060854Abx Pentra 400: LipoproteinsHoriba Abx200632
+2K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110—
+2K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+2K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—