510(k) Report

Devices descending from K955603

4 later devices reach Relsia SS-a/RO & SS/B LA Antibody Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983924Hep-2000 Colorzyme Ana-RO Test System, Model 4200-ROImmuno Concepts, Inc.19980—
+1K972145Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc.19982—
+2K131791Ifa 40: Hep-20-10Euroimmun US20140—
+2K060431Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation20060—