510(k) Report

Devices descending from K070458

1 later device reach Modification to Fidis Vasculitis, Model MX007 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100917Fidis Vasculitis Assay Kit and Analyzer and Caris SystemBiomedical Diagnostics (Bmd) SA20100—