510(k) Report

Devices descending from K070900

1 later device reach Freelite Human Kappa and Lambda Free Diagnostic Test Kits for Use on the Roche… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.20240—