510(k) K083799
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 2009
- Date Received
- December 22, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay, Anti-Seizure Drug
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type
To aid in management of patients treated with anti-seizure drug.