FDA applicant
Guangzhou Decheng Biotechnology Co., Ltd.
FDA records 8 decisions for Guangzhou Decheng Biotechnology Co., Ltd. (Guangzhou, CN) from 2022 to 2025: 8 510(k) clearances. Most are in product codes LCX (Kit, Test, Pregnancy, Hcg, Over The Counter) and NGL (Test, Opiates, Over The Counter). Since 2016 its 510(k)s took a median of 106 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Guangzhou Decheng Biotechnology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
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