Biolinq Incorporated FDA Approvals

0 new drug approvals and 2 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
Biolinq Shine Autonomous Time-in-Range Microsensor510(k)Sep 18, 2026Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Sep 18, 2026
Biolinq Shine Autonomous Time-in-Range Microsensor510(k)Sep 23, 2025Clinical Chemistry	Clinical Chemistry	510(k)Unknown (Direct)	Sep 23, 2025