510(k) Report

Devices descending from K992858

9 later devices reach Abbott Axsym Homocysteine through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073640Architect Homocysteine Reagents, Calibrators and ControlsAxis-Shield Diagnostics, Ltd.20080—
+1K061598Hemosil Homocysteine and ControlsInstrumentation Laboratory CO20060—
+1K052788N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HDade Behring, Inc.200642
+1K013606Acs 180 Homocysteine AssayBayer Diagnostics Corp.20010—
+1K013406Advia Centaur Homocysteine AssayBayer Diagnostics Corp.200102
+2K110874Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin CalibratorSiemens Healthcare Diagnostics, Inc.20120—
+2K083463Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension…Siemens Healthcare Diagnostics200904
+2K063206Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…Dade Behring, Inc.200613
+3K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories20070—