510(k) Report

Devices descending from K021316

9 later devices reach Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.20240—
+1K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)20160—
+1K103747Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G…Elitechgroup Seppim S.A.S.20110—
+1K072395Diazyme HDL-Cholesterol Reagent,Calibrator, ControlsDiazyme Laboratories20080—
+1K060854Abx Pentra 400: LipoproteinsHoriba Abx200632
+1K051962Ultra HDLAbbott Laboratories20050—
+1K041090HDL-EX Seiken Assay KitDenka Seiken Co., Ltd.20040—
+2K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+2K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—