510(k) Report

Devices descending from K011033

2 later devices reach Dimension Lithium (LI) Flex Reagent Cartridge, Model DF 132 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112142Dimension Vista Lithium Flex Reagent CartridgeSiemens Healthcare Diagnostics201101
+1K061792Dimension Vista Ethyl Alcohol (Alc), Alkaline Phosphatase (Alp), Calcium (CA0 Flex…Dade Behring, Inc.200602