510(k) Report

Devices descending from K053653

5 later devices reach Fidis Connective 10, Model MX006 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc.20162—
+1K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA20071—
+2K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+2K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.20180—
+2K102607Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA20100—