510(k) Report

Devices descending from K060628

1 later device reach Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.20230—