Guangzhou Wondfo Biotech Co., Ltd. - FDA 510(k) Cleared Devices
43
Total
43
Cleared
0
Denied
Guangzhou Wondfo Biotech Co., Ltd. has 43 FDA 510(k) cleared medical devices. Based in Yardley, US.
Latest FDA clearance: Apr 2026. Active since 2005. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Guangzhou Wondfo Biotech Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by LSI International, Inc. and Lsi International.
43 devices
Cleared
Apr 28, 2026
SAFElife T-Dip Multi-Drug Urine Test Panel
Toxicology
109d
Cleared
Nov 18, 2025
SAFElife T-Cup Multi-Drug Urine Test Cup
Toxicology
97d
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
Jul 16, 2024
SAFElife™ Fentanyl Urine Home Test (Cassette)
Toxicology
29d
Cleared
Sep 25, 2020
Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test...
Toxicology
21d
Cleared
Dec 03, 2018
Wondfo T-Cup Multi-Drug Urine Test Cup
Toxicology
67d
Cleared
Mar 12, 2018
Preview Digital Pregnancy Test
Chemistry
159d
Cleared
May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
Hematology
265d
Cleared
Jun 27, 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine...
Toxicology
59d
Cleared
Nov 23, 2015
Wondfo Propoxyphene Urine Test
Toxicology
83d
Cleared
Aug 07, 2015
Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine...
Chemistry
213d
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