# Guangzhou Wondfo Biotech Co., Ltd.

- Location (FDA's records): Gaithersburg, MD
- FDA decisions: 43 (2005–2026): 43 510(k) clearances
- Product codes: DJG (8), DKZ (6), DIO (4), NFT (4), LCX (3), LFG (2), DIS (2), LDJ (2), JXN (1), DJR (1), DJC (1), LAF (1)
- 510(k) review time since 2016: median 109 days, against 88 for FDA's reviews in the same codes and years (4 of 9 faster)
- Predicates its devices cite: 56 (20 its own); citations of its devices by later devices: 45 (20 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- ACON Laboratories, Inc.: 21 (https://510kreport.com/company/acon-laboratories)
- Medtox Diagnostics, Inc.: 3 (https://510kreport.com/company/medtox-diagnostics)
- Advin Biotech, Inc.: 2 (https://510kreport.com/company/advin-biotech)
- Ucp Biosciences, Inc.: 1 (https://510kreport.com/company/ucp-biosciences)
- Princeton BioMeditech Corp.: 1 (https://510kreport.com/company/princeton-biomeditech)
- Church & Dwight Co., Inc.: 1 (https://510kreport.com/company/church-dwight)
- Orient Gene Biotech: 1 (https://510kreport.com/company/orient-gene-biotech)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)

## Firms that cite its devices most
- Guangzhou Decheng Biotechnology Co., Ltd.: 4 (https://510kreport.com/company/guangzhou-decheng-biotechnology)
- Hangzhou AllTest Biotech Co., Ltd.: 2 (https://510kreport.com/company/hangzhou-alltest-biotech)
- Aicheck Biotech, Inc.: 2 (https://510kreport.com/company/aicheck-biotech)
- Vivachek Biotech (Hangzhou) Co., Ltd.: 2 (https://510kreport.com/company/vivachek-biotech-hangzhou)
- Qingdao Hightop Biotech Co., Ltd.: 2 (https://510kreport.com/company/qingdao-hightop-biotech)
- Hangzhou Aichek Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-aichek-medical-technology)
- Safecare Biotech (Hangzhou) Co., Ltd.: 1 (https://510kreport.com/company/safecare-biotech-hangzhou)
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)

## Its most-cited devices
- K043443: One Step HCG Urine Pregnancy Test (2005), cited by 9
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (2018), cited by 7
- K150022: Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream (2015), cited by 6
- K130665: Wondofo Multi-Drug Urine Test Cup / Panel (2013), cited by 3
- K202567: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx (2020), cited by 3
- K133343: Wondfo Rapid Strep a Test (2014), cited by 2

## Recent decisions
- K260065: SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel Dx (Apr 28, 2026)
- K252550: SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup Dx (Nov 18, 2025)
- K251289: WELLlife COVID-19 Antigen Test Rx (Oct 22, 2025)
- K241317: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) (Sep 30, 2024)
- K241741: 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 Panel (Jul 16, 2024)
- K202567: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx (Sep 25, 2020)
- K182701: Wondfo T-Cup Multi-Drug Urine Test Cup (Dec 3, 2018)
- K173229: Preview Digital Pregnancy Test (Mar 12, 2018)

Source page: https://510kreport.com/company/guangzhou-wondfo-biotech