510(k) K070645
K070645 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "SERADYN QMS TOPIRAMATE". The FDA issued a decision of Substantially Equivalent on May 17, 2007. The device falls under product code NWM (Immunoassay, Anti-Seizure Drug), a Class II device regulated under 21 CFR 862.3350. Seradyn, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 2007
- Date Received
- March 8, 2007
- 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.