FDA 510(k) Applications for Medical Device Product Code: LAO (Enzyme Immunoassay, Methotrexate)

FDA 510(k) Applications for Medical Device Product Code "LAO"
(Enzyme Immunoassay, Methotrexate)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K163359	ARK Diagnostics, Inc.	ARK Methotrexate Assay	08/18/2017
K232017	ARK Diagnostics, Inc.	ARK Methotrexate II Assay	12/20/2023
K111904	ARK DIAGNOSTICS,INC	ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN	10/18/2011
K233454	Roche Diagnostics Operations	ONLINE TDM Methotrexate	02/20/2024