510(k) Report

Devices descending from K053012

2 later devices reach Fidis Vasculitis, Model MX007 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070458Modification to Fidis Vasculitis, Model MX007Biomedical Diagnostics (Bmd) SA20071—
+2K100917Fidis Vasculitis Assay Kit and Analyzer and Caris SystemBiomedical Diagnostics (Bmd) SA20100—