Healstone Biotech, Inc. 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
Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx510(k)Aug 30, 2022Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Aug 30, 2022
hCG One Step Pregnancy Test510(k)Jun 30, 2022Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jun 30, 2022