510(k) Report

Devices descending from K110701

6 later devices reach Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192920Oragene®•DxDNA Genotek, Inc.20201—
+1K152464ORAcollect.DxDNA Genotek, Inc.201601
+1K152556Oragene DxDNA Genotek, Inc.20162—
+1K141410Oragene DX Ogd-500.001DNA Genotek, Inc.20153—
+2K212745ORAcollect®•DxDNA Genotek, Inc.20220—
+2K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc.20200—