510(k) Report

Devices descending from K111860

2 later devices reach BD Max GBS Assay, BD Max Instrument through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170557GenePOC GBS LBGenepoc, Inc.20171—
+2K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC20180—