Guangzhou Decheng Biotechnology Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Guangzhou Decheng Biotechnology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: MissLan® Early Detection Digital Pregnancy Test, Dochek® Multi-Drug Urine Test Cup, 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
8
Total
8
Cleared
0
Denied
Guangzhou Decheng Biotechnology Co., Ltd. has 8 FDA 510(k) cleared medical devices. Based in Guangzhou, CN.
Latest FDA clearance: Sep 2025. Active since 2022. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Guangzhou Decheng Biotechnology Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Lsi International and LSI International, Inc..
FDA 510(k) Regulatory Record - Guangzhou Decheng Biotechnology Co., Ltd.
8 devices
Cleared
Sep 09, 2025
MissLan® Early Detection Digital Pregnancy Test
Chemistry
159d
Cleared
Feb 20, 2025
Dochek® Multi-Drug Urine Test Cup
Toxicology
41d
Cleared
Feb 06, 2025
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus,...
Toxicology
175d
Cleared
Jun 21, 2024
MissLan® Early Detection Pregnancy Test Strip
Chemistry
106d
Cleared
May 10, 2024
Dochek® Multi-Drug Urine Test Dipcard Rx
Toxicology
57d
Cleared
Dec 13, 2023
Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
Toxicology
104d
Cleared
Feb 28, 2023
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
Chemistry
53d
Cleared
Nov 30, 2022
MissLan™ Digital Pregnancy Rapid Test
Chemistry
121d