Apex BioTechnology Corp. 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
UASure II Blood Uric Acid Monitoring System510(k)Apr 4, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 4, 2025
GlucoSure ADVANCE Link Blood Glucose Monitoring System510(k)Dec 21, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Dec 21, 2022
BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System510(k)Nov 4, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Nov 4, 2022
GlucoSure Link Blood Glucose Monitoring System510(k)Aug 25, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Aug 25, 2022
MTM301 Blood Glucose and Ketone Monitoring System510(k)Apr 6, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Apr 6, 2022
GAL-1A Plus Blood Glucose Monitoring System510(k)Mar 29, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Mar 29, 2022
MultiSure GK Link Blood Glucose and Ketone Monitoring System510(k)Oct 15, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 15, 2021
GlucoSure HT Plus Blood Glucose Monitoring System510(k)Sep 15, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Sep 15, 2021