First Light 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
The SensiTox B. anthracis Toxin Test510(k)Nov 20, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Nov 20, 2023
SensiTox C. difficile Toxin Test510(k)Jul 8, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 8, 2021