510(k) K252259
K252259 is an FDA 510(k) premarket notification submitted by Assure Tech., LLC for the device "AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup". The FDA issued a decision of Substantially Equivalent on August 15, 2025. The device falls under product code NFT (Test, Amphetamine, Over The Counter), a Class II device regulated under 21 CFR 862.3100. Assure Tech., LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2025
- Date Received
- July 21, 2025
- 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