Lumos Diagnostics, Inc. FDA Approvals

0 new drug approvals and 2 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
FebriDx Bacterial/Non-bacterial Assay510(k)Mar 24, 2026Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Mar 24, 2026
FebriDx Bacterial / Non-bacterial Point of Care Assay510(k)Jun 30, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jun 30, 2023