Randox Laboratories 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
Evidence MultiSTAT DOA Urine MultiPlex510(k)Jan 23, 2026Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Jan 23, 2026
Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT510(k)Oct 5, 2023Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Oct 5, 2023
Evidence MultiSTAT DOA Urine MultiPlex510(k)Oct 5, 2023Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Oct 5, 2023