510(k) Report

Devices descending from K935129

9 later devices reach Relisa Ena Antibody Screening Test System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K963275Relisa Ena Single Well Screen Antibody Test SystemImmuno Concepts, Inc.19960—
+1K955604Relisa SM/RNP Antibody Test SystemImmuno Concepts, Inc.19960—
+1K955605Relisa JO-1 Antibody Test SystemImmuno Concepts, Inc.19960—
+1K955603Relsia SS-a/RO & SS/B LA Antibody Test SystemImmuno Concepts, Inc.19964—
+1K955602Relsia SCL-70 Antibody Test SystemImmuno Concepts, Inc.19960—
+2K983924Hep-2000 Colorzyme Ana-RO Test System, Model 4200-ROImmuno Concepts, Inc.19980—
+2K972145Hep-2000 Fluorescent Ana-RO Test SystemImmuno Concepts, Inc.19982—
+3K131791Ifa 40: Hep-20-10Euroimmun US20140—
+3K060431Anti Rna Polymerase Iii Elisa Kit, Model 7805Mbl International Corporation20060—