510(k) Report

Devices descending from K141410

3 later devices reach Oragene DX Ogd-500.001 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc.20200—
+1K192920Oragene®•DxDNA Genotek, Inc.20201—
+2K212745ORAcollect®•DxDNA Genotek, Inc.20220—