510(k) K261409
K261409 is an FDA 510(k) premarket notification submitted by Bioteke Corporation (Wuxi) Co., Ltd. for the device "BioTeke® Multi-Drug Urine Test Cup". The FDA issued a decision of Substantially Equivalent on September 10, 2026. The device falls under product code NFT (Test, Amphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3100. Bioteke Corporation (Wuxi) Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2026
- Date Received
- April 30, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Amphetamine, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.3100
- Review Panel
- TX
- Submission Type