Bioteke Corporation (Wuxi) 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
BioTeke® Multi-Drug Urine Test Cup510(k)Sep 10, 2026Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Sep 10, 2026
BioTeke Sterile Disposable Virus Sampling Kit510(k)May 4, 2022Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	May 4, 2022