510(k) Report

Devices descending from K143651

1 later device reach Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitDiasorin Molecular, LLC20260—