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DNA Genotek, Inc.

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K254121	Colli-Pee•Dx Urine Collection Kit	SIH	2026-06-10	View
510(k)	K212745	ORAcollect®•Dx	OYJ	2022-10-27	View
510(k)	K192920	Oragene®•Dx	OYJ	2020-01-14	View
510(k)	K152556	Oragene Dx	OYJ	2016-05-26	View
510(k)	K152464	ORAcollect.Dx	OYJ	2016-05-26	View
510(k)	K110701	ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500	OYJ	2011-12-02	View

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