510(k) Report

Devices descending from K021646

7 later devices reach Binax Now Flu B Test (27 Test), Binax Now Nasopharyngeal Swab Specimen… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053126Binaxnow Influenza a & B TestBinax, Inc.20053—
+1K041626Immunocard Stat! Flu a & BMeridian Bioscience, Inc.20051—
+1K041049Binaxnow Influenza a & B TestBinax, Inc.20044—
+2K071657Tru FluMeridian Bioscience, Inc.20070—
+2K063689BD Directigen EZ Flu a+B TestBecton, Dickinson & CO20072—
+3K101461BD Directigen EX Flu a+BBecton, Dickinson and Company20100—
+3K101529BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO20100—