Inova Diagnostics, Inc. FDA Approvals

0 new drug approvals and 5 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
Aptiva APS IgA Reagent510(k)Feb 6, 2026Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Feb 6, 2026
Aptiva APS IgG Reagent; Aptiva APS IgM Reagent510(k)Dec 17, 2024Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Dec 17, 2024
Aptiva CTD Essential Reagent510(k)Sep 29, 2023Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 29, 2023
Aptiva Celiac Disease IgG Reagent510(k)Aug 26, 2021Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Aug 26, 2021
Aptiva Celiac Disease IgA Reagent510(k)Jun 16, 2021Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Jun 16, 2021