510(k) Report

Devices descending from K113382

2 later devices reach Ace Alt Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC201301
+1K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann20130—