FDA 510(k) Application Details - K233454

Device Classification Name	Enzyme Immunoassay, Methotrexate   More FDA Info for this Device
510(K) Number	K233454
Device Name	Enzyme Immunoassay, Methotrexate
Applicant	Roche Diagnostics Operations 9115 Hague Road Indianapolis, IN 46250 US Other 510(k) Applications for this Company
Contact	Elina Voronovsky 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	10/20/2023
Decision Date	02/20/2024
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