Ark Diagnostics, Inc. FDA Approvals

0 new drug approvals and 4 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
ARK Levetiracetam II Assay510(k)Feb 27, 2024Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Feb 27, 2024
ARK Methotrexate II Assay510(k)Dec 20, 2023	—	510(k)Substantially Equivalent (Traditional)	Dec 20, 2023
ARK Hydrocodone Assay510(k)Nov 9, 2023Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Nov 9, 2023
ARK Lacosamide Assay510(k)Aug 5, 2021Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Aug 5, 2021