Meridian Bioscience, Inc. FDA Approvals

0 new drug approvals and 6 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
Revogene510(k)Mar 20, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Mar 20, 2025
Premier HpSA Flex (619096)510(k)Jul 3, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jul 3, 2023
Curian® Shiga Toxin510(k)Apr 17, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 17, 2023
Revogene510(k)Jan 26, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Jan 26, 2023
Revogene510(k)Jul 11, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 11, 2022
Curian Campy510(k)Dec 23, 2021Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Dec 23, 2021