510(k) Report

Devices descending from K111904

2 later devices reach Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233454ONLINE TDM MethotrexateRoche Diagnostics Operations20240—
+1K232017ARK Methotrexate II AssayArk Diagnostics, Inc.20230—