Anhui Deepblue Medical Technology 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
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)510(k)Oct 11, 2024Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Oct 11, 2024
Sterile and Non-Sterile Ultrasonic Coupling Agent510(k)Sep 19, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Sep 19, 2024