510(k) Report

Devices descending from K023158

4 later devices reach Randox Apolipoprotein Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041870N Apolipoprotein Standard SerumDade Behring, Inc.20043—
+2K063608Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and…Dade Behring, Inc.20071—
+2K042521Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1…Ortho-Clinical Diagnostics, Inc.20040—
+3K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings20180—