510(k) Report

Devices descending from K113253

4 later devices reach Ace Axcel Clinical Chemistry System,Ace Albumin Reagent,Ace Total Protein… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131488Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…Alfa Wassermann Diagnostics Technologies, LLC20130—
+1K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC201301
+1K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann20130—
+1K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…Alfa Wassermann Diagnostic Technologies, Inc.20130—