Luminex Corporation 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
LIAISON PLEX Gastrointestinal Flex Assay510(k)May 19, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	May 19, 2026
LIAISON PLEX Gram-Positive Blood Culture Assay510(k)Jun 6, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jun 6, 2025
LIAISON PLEX Gram-Negative Blood Culture Assay510(k)Apr 18, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 18, 2025
LIAISON PLEX Yeast Blood Culture Assay510(k)Jun 4, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jun 4, 2024
LIAISON PLEX Respiratory Flex Assay510(k)Mar 1, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Mar 1, 2024