510(k) Report

Devices descending from K983849

6 later devices reach Dimension Automated High Density Lipoprotein Cholesterol (Adhl) Flex Reagent… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032798Dimension Automated HDL Cholesterol (Ahdl) Flex Reagent Cartridge (DF48A) Catalog # DF48ADade Behring, Inc.20035—
+2K073072Dimension Ahdl Flex Reagent Cartridge, Model: DF48BDade Behring, Inc.200812
+2K042006Vitros Chemistry Products DHDL Slides, Vitros Chemistry Products Calibrator Kit 25…Ortho-Clinical Diagnostics, Inc.200423
+3K120609Vitros Chemistry Products DHDL SlidesOrtho-Clinical Diagnostics, Inc.201201
+3K081300Dimension Vista HDLC Flex Reagent CartridgeSiemens Healthcare Diagnostics200802
+3K052867Vitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc.200501