Guangzhou Wondfo Biotech Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx510(k)Apr 28, 2026Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Apr 28, 2026
SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx510(k)Nov 18, 2025Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Nov 18, 2025
WELLlife COVID-19 Antigen Test Rx510(k)Oct 22, 2025Microbiology	Microbiology	510(k)Substantially Equivalent (Dual Track)	Oct 22, 2025
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)510(k)Sep 30, 2024Microbiology	Microbiology	510(k)Substantially Equivalent (Traditional)	Sep 30, 2024
SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife T-Dip Fentanyl (FTY) Urine Test Panel510(k)Jul 16, 2024Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Jul 16, 2024