510(k) Report

Devices descending from K932615

3 later devices reach TDX (R)/TDX (R)FLX (R)Mehtotrexate II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111904Ark Methotrexate Assay, Ark Methotrexate Calibrator, Ark Methotrexate Control, Ark…Ark Diagnostics, Inc.20112—
+2K233454ONLINE TDM MethotrexateRoche Diagnostics Operations20240—
+2K232017ARK Methotrexate II AssayArk Diagnostics, Inc.20230—