Abbott Ireland 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
Glucose2510(k)Oct 24, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 24, 2025
Calcium2510(k)Feb 10, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Feb 10, 2025