510(k) 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 by Guangzhou Decheng Biotechnology Co., Ltd. — Product Code NGL

K242428 is an FDA 510(k) premarket notification submitted by Guangzhou Decheng Biotechnology Co., Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on February 6, 2025. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650. Guangzhou Decheng Biotechnology Co., Ltd. has at least 7 other 510(k) clearances on record.