Assure Tech. (Hangzhou) Co, Ltd. 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
FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream510(k)Feb 5, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Feb 5, 2024
AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests510(k)Aug 12, 2021Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Aug 12, 2021