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
K111904 ARK DIAGNOSTICS,INC ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN 10/18/2011


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