510(k) Report

Devices descending from K971573

21 later devices reach N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator… 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—
+1K072523Diazyme LDL-Cholesterol Reagent, Calibrator and ControlsGeneral Atomics20080—
+1K060854Abx Pentra 400: LipoproteinsHoriba Abx200632
+1K043264LDL-EX Seiken Assay KitDenka Seiken Co., Ltd.20050—
+1K020724Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131Dade Behring, Inc.20028—
+1K014103Synchron Systems Direct LDL Chloesterol Reagent and CalibratorBeckman Coulter, Inc.200201
+1K991733Ace LDL-C Reagent, LDL-C Calibrator, LDL-C ControlsSchiapparelli Biosystems, Inc.19994—
+2K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.20240—
+2K113262Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20121—
+2K112538Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120—
+2K102993Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SLSeppim S.A.S.20110—
+2K091333S-Test LDL Cholesterol (LDL), Model RC0022Alfa Wassermann, Inc.20090—
+2K063841NMR Profiler and NMR Lipoprofile Assay, ControlsLiposcience20084—
+2K062737Cardiac Markers on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx20070—
+2K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.200617
+3K210801AXINON® LDL-p Test SystemNumares AG20230—
+3K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502
+3K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120—
+3K111516NMR Lipoprofile (R) Test and NMR ProfilerLiposcience, Inc.20112—
+4K113830Vantera Clinical AnalyzerLiposcience20121—
+5K133849Vantera Clinical AnalyzerLiposcience20140—