510(k) Report

Devices descending from K930104

7 later devices reach Ace Clinical Chemistry System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131975Ace Direct Total Iron-Binding Capacity (Tibc) Reagent, Ace Total Iron Reagent, Ace LDH-L…Alfa Wassermann Diagnostic Technologies, Inc.20130—
+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—
+1K123322Ace Bun/Urea Reagent, Ace Creatinine Reagent, Ace Uric Acid Reagent, Ace CK ReagentAlfa Wassermann Diagnostics Technologies, LLC20130—
+1K123018Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…Alfa Wassermann Diagnostic Technologies, Inc.20130—
+1K113389Ace CK Reagent,Ace Bun/Urea Reagent,Ace Uric Acid Reagent,Ace Creatinine ReagentAlfa Wassermann Diagnostic Technologies, Inc.20120—