510(k) Report

Devices descending from K041870

3 later devices reach N Apolipoprotein Standard Serum through their predicates, nearest generation first.

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