Microgenics Corporation FDA Approvals

0 new drug approvals and 6 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
Alinity c Benzodiazepines Reagent Kit510(k)Dec 11, 2024Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Special)	Dec 11, 2024
DRI Ecstasy Plus Assay510(k)Oct 30, 2024Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Special)	Oct 30, 2024
Alinity c Tricyclic Antidepressants Reagent Kit510(k)Nov 17, 2023Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Nov 17, 2023
CEDIA Heroin Metabolite (6-AM) Assay510(k)Sep 27, 2023Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Sep 27, 2023
DRI TM Tricyclics Serum Tox Assay510(k)Dec 21, 2022Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Dec 21, 2022
DRI Cocaine Metabolite Assay510(k)Sep 24, 2021Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Sep 24, 2021