510(k) K232522
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2024
- Date Received
- August 18, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Levetiracetam Assay
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type
For the quantitative determination of levetiracetam in human serum or plasma.