510(k) Report

Devices descending from K042472

2 later devices reach BD Directigen EZ Flu a + B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101461BD Directigen EX Flu a+BBecton, Dickinson and Company20100—
+1K101529BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO20100—