Meridian Bioscience Israel , Ltd. 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
BreathID Hp System510(k)Dec 19, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Dec 19, 2022
BreathID® Smart System510(k)Nov 10, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Nov 10, 2022
BreathID Hp Lab System, BreathID Smart System510(k)Jun 23, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Special)	Jun 23, 2022