510(k) K220046
K220046 is an FDA 510(k) premarket notification submitted by Shenzhen Superbio Technology Co., Ltd. for the device "Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11". The FDA issued a decision of Substantially Equivalent on Dec 13, 2022. The device falls under product code DJG (Enzyme Immunoassay, Opiates), a Class II device regulated under 21 CFR 862.3650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 13, 2022
- Date Received
- Jan 5, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Opiates
- Device Class
- Class II
- Regulation Number
- 862.3650
- Review Panel
- TX
- Submission Type
- 510(k)