NWM
5 FDA 510(k) clearances · Product code
168 daysmedian time to decision
469 days90th percentile
5clearances measured
FDA profile
- Official device name
- Immunoassay, Anti-Seizure Drug
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3350
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- FDA definition
- To aid in management of patients treated with anti-seizure drug.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ARK Lacosamide Assay (K201089) | Ark Diagnostics, Inc. | 2021-08-05 |
| ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003 (K091884) | Ark Diagnostics, Inc. | 2009-12-09 |
| TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 (K083799) | Ark Diagnostics, Inc. | 2009-04-16 |
| SERADYN QMS TOPIRAMATE (K070645) | Seradyn, Inc. | 2007-05-17 |
| QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (K051211) | Seradyn, Inc. | 2005-11-18 |
Track NWM automatically
Every clearance here is in the API, with alerts when new ones post.