510(k) K250803
K250803 is an FDA 510(k) premarket notification submitted by Anhui Deepblue Medical Technological Co., Ltd. for the device "Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup". The FDA issued a decision of Substantially Equivalent on April 15, 2025. The device falls under product code NGL (Test, Opiates, Over The Counter), a Class II device regulated under 21 CFR 862.3650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2025
- Date Received
- March 17, 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