510(k) Report

Devices descending from K902609

46 later devices reach Directigen Flu a through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K981651AB Flu OiaBiostar, Inc.199845—
+2K023556Flu Oia a/B Test KitThermo Biostar, Inc.2003401
+2K021172RSV OiaThermo Biostar, Inc.20023—
+3K041626Immunocard Stat! Flu a & BMeridian Bioscience, Inc.20051—
+3K041049Binaxnow Influenza a & B TestBinax, Inc.20044—
+3K031899Quickvue Influenza a+B TestQuidel Corp.200334—
+3K023779RSV OiaThermo Biostar, Inc.20032—
+4K092698Quickvue Influenza a+B TestQuidel Corp.200924—
+4K071657Tru FluMeridian Bioscience, Inc.20070—
+4K051244Genzyme Osom Influenza a & B TestGenzyme Corp.20063—
+4K053146Quickvue Influenza a + B TestQuidel Corp.200527—
+4K053126Binaxnow Influenza a & B TestBinax, Inc.20053—
+4K041445Immunocard Stat! RSV Model #750630Meridian Bioscience, Inc.20041—
+5K121797BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company20126—
+5K120049BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company20126—
+5K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company2011201
+5K083746Biosign Flu a+BPrinceton BioMeditech Corp.201003
+5K083278Avc a/H5N1 Flu TestArbor Vita Corportation20090—
+5K071101Tru RSVMeridian Bioscience, Inc.20070—
+5K063689BD Directigen EZ Flu a+B TestBecton, Dickinson & CO20072—
+5K061508Osom Influenza a&B TestGenzyme Corp.20062—
+6K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd20232—
+6K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd201852
+6K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO20160—
+6K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO20169—
+6K152870BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co.201510—
+6K152874BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitBecton, Dickinson and Co.20151—
+6K151291BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company201511—
+6K151301BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company20152—
+6K133140BD Veritor System for the Rapid Detection of RSVBecton, Dickinson & CO20130—
+6K133138BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO20133—
+6K132693BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company20133—
+6K132692BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company201317—
+6K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company201319—
+6K132256BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company20135—
+6K101461BD Directigen EX Flu a+BBecton, Dickinson and Company20100—
+6K101529BD Directigen EZ Flu a+B AssayBecton, Dickinson & CO20100—
+6K092633Osom Influenza a&B Test , Model PN190Genzyme Corporation20091—
+7K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd20231—
+7K191514CareStart Flu A&B PlusAccess Bio, Inc.20201—
+7K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Alere Scarborough, Inc.20172—
+7K123182Osom Influenza a&B Test Model 190SEKISUI Diagnostics, LLC20120—
+8K252283Nano-Check Influenza A+B TestNano-Ditech Corporation20260—
+8K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.20250—
+8K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Alere Scarborough, Inc.20171—
+9K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderAlere Scarborough, Inc.20180—