FDA 510(k) Application Details - K232522

Device Classification Name	Levetiracetam Assay   More FDA Info for this Device
510(K) Number	K232522
Device Name	Levetiracetam Assay
Applicant	ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Dionne Labatore Other 510(k) Applications for this Contact
Regulation Number	862.3350   More FDA Info for this Regulation Number
Classification Product Code	ORI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2023
Decision Date	02/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review