510(k) Report

Devices descending from K031565

7 later devices reach Xpect Influenza a/B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131804Remel Xpect Flu a&BRemel, Inc.20130—
+1K092423Xpect Flu a & BThermo Fisher Scientific20090—
+1K042472BD Directigen EZ Flu a + BBecton, Dickinson & CO20052—
+1K041626Immunocard Stat! Flu a & BMeridian Bioscience, Inc.20051—
+2K101461BD Directigen EX Flu a+BBecton, Dickinson and Company20100—
+2K101529BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO20100—
+2K071657Tru FluMeridian Bioscience, Inc.20070—