DNA Genotek, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ORAcollect®•Dx, Oragene®•Dx
8
Total
7
Cleared
1
Denied
FDA 510(k) Regulatory Record - DNA Genotek, Inc. Chemistry ✕
6 devices
Cleared
Oct 27, 2022
ORAcollect®•Dx
Chemistry
423d
Cleared
Jan 14, 2020
Oragene®•Dx
Chemistry
90d
Cleared
May 26, 2016
ORAcollect.Dx
Chemistry
269d
Cleared
May 26, 2016
Oragene Dx
Chemistry
261d
Cleared
Feb 19, 2015
ORAGENE DX OGD-500.001
Chemistry
266d
Cleared
Dec 02, 2011
ORAGENE-DX OGD-500
Chemistry
263d