Abbott Laboratories Diagnostics Division FDA Approvals

0 new drug approvals and 3 device clearances on file. Matched by name to ABT.

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 Phosphatase510(k)Oct 16, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Oct 16, 2024
Alinity i STAT High Sensitivity Troponin-I510(k)May 4, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	May 4, 2023
Alinity i STAT High Sensitivity Troponin-I510(k)May 19, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	May 19, 2022