Medical Device Manufacturer · US , Yardley , PA

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

43 submissions · 43 cleared · Since 2005

43

Total

43

Cleared

0

Denied

FDA 510(k) Regulatory Record - Guangzhou Wondfo Biotech Co., Ltd. Microbiology ✕

3 devices

1-3 of 3

Cleared Oct 22, 2025

WELLlife COVID-19 Antigen Test Rx

Microbiology · 180d

Cleared Sep 30, 2024

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

Microbiology · 143d

Cleared Jan 31, 2014

WONDFO RAPID STREP A TEST

Microbiology · 93d