Guangzhou Wondfo Biotech Co., Ltd. - FDA 510(k) Cleared Devices

Guangzhou Wondfo Biotech Co., Ltd. is a leading in vitro diagnostic (IVD) company founded in 1992. The company specializes in rapid point-of-care testing (POCT) devices and reagents. Wondfo operates with a manufacturing facility in Yardley, US, and serves over 150 countries globally.

Wondfo has received 43 FDA 510(k) clearances from 43 total submissions since 2005. The company's regulatory portfolio is dominated by toxicology devices, including multi-drug urine test panels, cups, and dipsticks for substance screening. The latest clearance was in 2026, confirming active regulatory engagement.

The company operates nine technology platforms spanning colloidal gold, immunofluorescence, chemiluminescence, coagulation, blood gas, molecular diagnostics, pathology, and HPLC hemoglobin analysis. Wondfo's product range addresses cardiovascular disease, diabetes, renal function, infectious disease, fertility testing, and drug-of-abuse (DOA) screening. In 2015, Wondfo became the first POCT company listed on the Shenzhen Stock Exchange.

Explore the complete list of FDA 510(k) cleared devices, product codes, and clearance dates in the database.

Regulatory submissions have been managed by LSI International, Inc. and Lsi International.