510(k) Report

Devices descending from K053126

3 later devices reach Binaxnow Influenza a & B Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063689BD Directigen EZ Flu a+B TestBecton, Dickinson & CO20072—
+2K101461BD Directigen EX Flu a+BBecton, Dickinson and Company20100—
+2K101529BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO20100—