510(k) Report

Devices descending from K010871

3 later devices reach TGL Flex Reagent Cartridge through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133067Advia Chemistry Triglycerides_2 (Trig_2) ReagentSiemens Healthcare Diagnostics, Inc.201303
+1K061655Dimension Vista Flex Reagent CartridgesDade Behring, Inc.200617
+2K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics201502