Abbott Ireland Diagnostics Division FDA Approvals

0 new drug approvals and 8 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
Alkaline Phosphatase2510(k)Jul 21, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jul 21, 2023
Total Bilirubin2510(k)Dec 29, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Dec 29, 2022
Cholesterol2510(k)Jun 30, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jun 30, 2022
Urea Nitrogen2510(k)May 31, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 31, 2022
Amylase2510(k)May 26, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 26, 2022
Creatinine2510(k)Mar 22, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Mar 22, 2022
Albumin BCP2510(k)Mar 18, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Mar 18, 2022
Albumin BCG2510(k)Nov 23, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Nov 23, 2021