510(k) Report

Devices descending from K023009

1 later device reach Freelite Human Kappa and Human Lambda Free Kits for Use on the Hitachi 911/912… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153394Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay…Diazyme Laboratories20160—