510(k) Report

Devices descending from K862359

6 later devices reach Meth./Cali./Intru. Check for the Dimension System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061839Dimension Vista Dbil Flex Reagent Cartridge, Model K2125Dade Behring, Inc.20060—
+1K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.200617
+1K061020Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…Dade Behring, Inc.200601
+1K060628Dimension Tbi Flex and Dbi Flex Reagent Cartridges and Tbi/Dbi CalibratorDade Behring, Inc.200611
+2K222104Atellica® CH Diazo Total Bilirubin (D_TBil)Siemens Healthcare Diagnostics, Inc.20230—
+2K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502