510(k) Report

Devices descending from K991733

4 later devices reach Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113262Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20121—
+1K112538Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120—
+1K091333S-Test LDL Cholesterol (LDL), Model RC0022Alfa Wassermann, Inc.20090—
+2K122757Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120—