Shenzhen Dakewe Bio-Engineering Co., Ltd. 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
OmniTrans Transport System510(k)Aug 19, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Aug 19, 2024
BioSci Disposable Virus Sampling Tubes510(k)Apr 5, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Apr 5, 2023
Biosci Inactivated Transport Medium, Biosci ITM510(k)Jan 19, 2023Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Jan 19, 2023