510(k) Report

Devices descending from K113435

1 later device reach Ace Carbon Dioxide (CO2-LC) Reagent, Ace Direct Bilirubin Reagent, Ace Total… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122302Ace Magnesium RegentAlfa Wassermann Diagnostics Technologies, LLC20120—