510(k) Report

Devices descending from K113374

1 later device reach Ace Albumin Reagent Ace Total Protein Reagent Ace Calcium-Arsenazo Reagent Ace… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131488Ace Albumin Reagent, Ace Total Protein Reagent, Ace Calcium-Arsenazo Reagent and Ace…Alfa Wassermann Diagnostics Technologies, LLC20130—