Safecare Biotech (Hangzhou) 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
Safecare Urinary Tract Infection Test510(k)Jan 10, 2025Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Jan 10, 2025
SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette510(k)Apr 10, 2024Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Apr 10, 2024
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card510(k)Mar 24, 2021Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Mar 24, 2021