DNA Genotek, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Colli-PeeDx Urine Collection Kit510(k)Jun 10, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jun 10, 2026
ORAcollect®Dx510(k)Oct 27, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 27, 2022
OMNIgene GUT Dx510(k)Nov 3, 2021Microbiology	Microbiology	510(k)Unknown (Direct)	Nov 3, 2021