510(k) Report

Devices descending from K052017

1 later device reach Cyclosporine Extended Range Assay (Csae) Flex Reagent Cartridge, Catalog # DF108 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081992Dimension Vista Csae Flex Regent Cartridge, Model K4108Siemens Healthcare Diagnostics, Inc.20080—