Product code NWM— Clinical Toxicology
ARK Lacosamide Assay
- Classification name
- Immunoassay, Anti-Seizure Drug
- Device class
- Class 2
- Regulation
- 21 CFR 862.3350
- Advisory panel
- Clinical Toxicology
- Total cleared
- 5
- First cleared
- Most recent
FDA classification definition
“To aid in management of patients treated with anti-seizure drug.”
Market context for product code NWM
FDA has cleared devices under product code NWM between 2005 and 2021, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2021
- 2009
- 2007
- 2005
Top applicants under product code NWM
Recent clearances under product code NWM
- K201089 — ARK Lacosamide Assay
- K091884 — ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
- K083799 — TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
- K070645 — SERADYN QMS TOPIRAMATE
- K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.