510(k) Report

Devices descending from K062128

1 later device reach The Dimension Vista Flex Reagent Cartridges / Kit Assays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc.201103