510(k) Report

Devices descending from K163626

2 later devices reach ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC20181—
+2K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC20180—