510(k) Report

Devices descending from K133673

5 later devices reach Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex Corporation201721
+1K170284Great Basin Bordetella Direct TestGreat Basin Scientific, Inc.20170—
+1K143206AmpliVue Bordetella AssayQuidel Corporation20140—
+2K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC20181—
+3K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC20180—