Immunodiagnostic Systems Limited 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
IDS-iSYS Total Testosterone510(k)Apr 15, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 15, 2026
IDS-iSYS Free Testosterone510(k)Oct 23, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 23, 2024
IDS ACTH II510(k)Aug 18, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 18, 2023