Bionime Corporation 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
RIGHTEST Blood Glucose Monitoring System Max Tel510(k)Nov 4, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Nov 4, 2024
RIGHTEST Blood Glucose Monitoring System Max Tel510(k)Jan 19, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 19, 2024
RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device510(k)Sep 26, 2022General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 26, 2022