510(k) Report

Devices descending from K862008

2 later devices reach Mono-Latex (TM) Slide Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062213Bioplex 2200 Ebv Igm Panel on Bioplex 2200 Multi-Analyte Detection SystemBio-Rad Laboratories, Inc.200611
+2K123021Bioplex 2200 Ebv Igm KitBio-Rad Laboratories20120—