510(k) Report

Devices descending from K113436

1 later device reach Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L Reagent through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131351Ace Alkaline Phosphatase Reagent, Amylase Reagent, Alt Reagent, Ast ReagentAlfa Wassermann Diagnostic Technologies, LLC201301