510(k) Report

Devices descending from K981375

2 later devices reach Ace T Uptake Reagent TU Calibrators through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113437Ace Hemoglobin Alc (Hbalc) Reagent, Ace Cedia T Uptake Reagent, Ace T4 Reagent, Ace…Alfa Wassermann Diagnostic Technologies, Inc.20121—
+2K131515Ace -GT Reagent; Ace Lipase Ragent; Ace T4 ReagentAlfa Wassermann20130—