510(k) Report

Devices descending from K021486

2 later devices reach Herpeselect 2 Elisa Igg, Model ELO920G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090409Bioplex 2200 HSV-1 and HSV-2 Igg on the Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories20091—
+2K120959Bioplex 2200 HSV-1 and HSV-2 Igg KitBio-Rad Laboratories20120—