510(k) Report

Devices descending from K132555

1 later device reach Hevylite Human Igg Kappa Kit and Hevylite Human Igg Lambda Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172613Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda KitThe Binding Site Group, Ltd.20180—