DNA Genotek, Inc. is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
DNA Genotek, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ORAcollect®•Dx, Oragene®•Dx
8
Total
7
Cleared
1
Denied
DNA Genotek, Inc. has 7 FDA 510(k) cleared medical devices. Based in Ottawa Ontario, CA.
Latest FDA clearance: Jun 2026. Active since 2011. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by DNA Genotek, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - DNA Genotek, Inc.
8 devices
Cleared
Jun 10, 2026
Colli-Pee•Dx Urine Collection Kit
Microbiology
173d
Cleared
Oct 27, 2022
ORAcollect®•Dx
Chemistry
423d
Not Cleared
Nov 03, 2021
OMNIgene GUT Dx
Microbiology
506d
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