510(k) Report

Devices descending from K963498

2 later devices reach Ferr Flex Reagent Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112999Dimension Clinical Chemistry SystemSiemens Healthcare Diagnostics201107
+1K070552Dimension Vista Ferritin Flex Reagent Cartridge (Ferr)Dade Behring, Inc.200701