FDA 510(k) Application Details - K232017

Device Classification Name	Enzyme Immunoassay, Methotrexate   More FDA Info for this Device
510(K) Number	K232017
Device Name	Enzyme Immunoassay, Methotrexate
Applicant	ARK Diagnostics, Inc. 48089 Fremont Boulevard Fremont, CA 94538 US Other 510(k) Applications for this Company
Contact	Thomas Houts Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LAO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2023
Decision Date	12/20/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review