510(k) Report

Devices descending from K994115

2 later devices reach Total Iron Binding Capacity (Ibct) Flex Reagent Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…Dade Behring, Inc.200601
+1K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc.200501