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
FDA 510(k) Regulatory Record - Guangzhou Decheng Biotechnology Co., Ltd. Chemistry ✕
4 devices
Cleared
Sep 09, 2025
MissLan® Early Detection Digital Pregnancy Test
Chemistry
159d
Cleared
Jun 21, 2024
MissLan® Early Detection Pregnancy Test Strip
Chemistry
106d
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