I-Sens, Inc. 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
ReliOn Premier BLU Blood Glucose Monitoring System510(k)Aug 10, 2023Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Aug 10, 2023
LDE4 Lancing Device510(k)Nov 23, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Nov 23, 2022
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System510(k)Oct 5, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Special)	Oct 5, 2021