FDA 510(k) Applications for Medical Device Product Code: NWM (Immunoassay, Anti-Seizure Drug)

FDA 510(k) Applications for Medical Device Product Code "NWM"
(Immunoassay, Anti-Seizure Drug)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K201089	ARK Diagnostics, Inc.	ARK Lacosamide Assay	08/05/2021
K091884	ARK DIAGNOSTICS,INC	ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODELS 5022-0001-00, 5022-0002-00, 5022-0003	12/09/2009
K083799	ARK DIAGNOSTICS,INC	TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00	04/16/2009
K051211	SERADYN INC.	QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS	11/18/2005
K070645	SERADYN INC.	SERADYN QMS TOPIRAMATE	05/17/2007