510(k) K250067

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro by Guangzhou Decheng Biotechnology Co., Ltd. — Product Code NGL

K250067 is an FDA 510(k) premarket notification submitted by Guangzhou Decheng Biotechnology Co., Ltd. for the device "Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro". The FDA issued a decision of Substantially Equivalent on February 20, 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2025
Date Received
January 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Opiates, Over The Counter
Device Class
Class II
Regulation Number
862.3650
Review Panel
TX
Submission Type