NWM · Class II · 21 CFR 862.3350

FDA Product Code NWM: Immunoassay, Anti-seizure Drug

To Aid In Management Of Patients Treated With Anti-seizure Drug.

Leading manufacturers include ARK Diagnostics, Inc. and Seradyn, Inc..

5
Total
5
Cleared
203d
Avg days
2005
Since

FDA 510(k) Cleared Immunoassay, Anti-seizure Drug Devices (Product Code NWM)

5 devices
1–5 of 5
Cleared Aug 05, 2021
ARK Lacosamide Assay
K201089
ARK Diagnostics, Inc.
Toxicology · 469d
Cleared Dec 09, 2009
ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003
K091884
ARK Diagnostics, Inc.
Toxicology · 168d
Cleared Apr 16, 2009
TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00
K083799
ARK Diagnostics, Inc.
Toxicology · 115d
Cleared May 17, 2007
SERADYN QMS TOPIRAMATE
K070645
Seradyn, Inc.
Toxicology · 70d
Cleared Nov 18, 2005
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
K051211
Seradyn, Inc.
Chemistry · 191d

About Product Code NWM - Regulatory Context