510(k) Report

Devices descending from K091616

2 later devices reach Bioplex 2200 MMRV Igg through their predicates, nearest generation first.

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