510(k) Report

Devices descending from K961053

3 later devices reach Seraquest Rubella Igg through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K091616Bioplex 2200 MMRV IggBio-Rad Laboratories20102—
+2K212769DYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc.20230—
+2K111072Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200…Bio-Rad Laboratories20110—