NWM — Immunoassay, Anti-Seizure Drug Class II
Classification Details
- Product Code
- NWM
- Device Class
- Class II
- Regulation Number
- 862.3350
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Definition
To aid in management of patients treated with anti-seizure drug.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K201089 | ark diagnostics | ARK Lacosamide Assay | August 5, 2021 |
| K091884 | ark diagnostics | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODE | December 9, 2009 |
| K083799 | ark diagnostics | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5 | April 16, 2009 |
| K070645 | seradyn | SERADYN QMS TOPIRAMATE | May 17, 2007 |
| K051211 | seradyn | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | November 18, 2005 |