510(k) Report

Devices descending from K962186

5 later devices reach N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971190N-Geneous HDL Cholesterol Kit/Cholesterol CalibratorGenzyme Corp.19970—
+1K971526Ace HDL-C ReagentSchiapparelli Biosystems, Inc.19973—
+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—
+3K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120—