Guangzhou Decheng Biotechnology Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestSeptember 9, 2025
K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup ProFebruary 20, 2025
K242428Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine TeFebruary 6, 2025
K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MisJune 21, 2024
K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardMay 10, 2024
K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test CupDecember 13, 2023
K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)February 28, 2023
K222305MissLan™ Digital Pregnancy Rapid TestNovember 30, 2022