510(k) Report

Devices descending from K042629

7 later devices reach Varelisa SM Antibodies, Model 18296 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA20065—
+1K050625Varelisa Recombi Ana Profile, Model 18496Sweden Diagnostics (Germany) GmbH20050—
+2K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc.20162—
+2K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA20071—
+3K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+3K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.20180—
+3K102607Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA20100—