510(k) K250067
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