# Guangzhou Decheng Biotechnology Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 8 (2022–2025): 8 510(k) clearances
- Product codes: LCX (4), NGL (2), DJG (2)
- 510(k) review time since 2016: median 106 days, against 132 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 8 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Guangzhou Wondfo Biotech Co., Ltd.: 4 (https://510kreport.com/company/guangzhou-wondfo-biotech)
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)
- Assure Tech. (Hangzhou) Co, Ltd.: 1 (https://510kreport.com/company/assure-tech-hangzhou)

## Firms that cite its devices most
- Hangzhou AllTest Biotech Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-alltest-biotech)
- Healgen Scientific,, LLC: 1 (https://510kreport.com/company/healgen-scientific)

## Its most-cited devices
- K232659: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (2023), cited by 3
- K222305: MissLan™ Digital Pregnancy Rapid Test (2022), cited by 1

## Recent decisions
- K251040: MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test (Sep 9, 2025)
- K250067: Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro (Feb 20, 2025)
- K242428: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus (Feb 6, 2025)
- K240643: MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream (Jun 21, 2024)
- K240698: Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard (May 10, 2024)
- K232659: Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup (Dec 13, 2023)
- K230038: MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) (Feb 28, 2023)
- K222305: MissLan™ Digital Pregnancy Rapid Test (Nov 30, 2022)

Source page: https://510kreport.com/company/guangzhou-decheng-biotechnology
