510(k) Report

Devices descending from K000312

10 later devices reach Varelisa SM Antibodies through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082759Elia Cenp Immunoassay, Elia U1RNP Immunoassay, Elia SM Immunoassay, Elia RO ImmunoassayPhadia US, Inc.20091—
+1K042629Varelisa SM Antibodies, Model 18296Sweden Diagnostics (Germany) GmbH20047—
+2K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia AB20180—
+2K053653Fidis Connective 10, Model MX006Biomedical Diagnostics (Bmd) SA20065—
+2K050625Varelisa Recombi Ana Profile, Model 18496Sweden Diagnostics (Germany) GmbH20050—
+3K151429QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 CiontrolsInova Diagnostics, Inc.20162—
+3K071210Modification to Fidis Connective 10*, Model MX006Biomedical Diagnostics (Bmd) SA20071—
+4K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc.20230—
+4K180975QUANTA Flash HMGCR ReagentsInova Diagnostics, Inc.20180—
+4K102607Fidistm Connective 10, Fidistm Analyzer, CarisBiomedical Diagnostics (Bmd) SA20100—