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DNA Genotek, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories2
Latest FDA decision2026-06-10
TypeNumberDevice NameCodeDateActions
510(k) K254121 Colli-Pee•Dx Urine Collection KitSIH2026-06-10 View
510(k) K212745 ORAcollect®•DxOYJ2022-10-27 View
510(k) K192920 Oragene®•DxOYJ2020-01-14 View
510(k) K152556 Oragene DxOYJ2016-05-26 View
510(k) K152464 ORAcollect.DxOYJ2016-05-26 View
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