510(k) Report

Devices descending from K152556

2 later devices reach Oragene Dx through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192920Oragene®•DxDNA Genotek, Inc.20201—
+2K212745ORAcollect®•DxDNA Genotek, Inc.20220—