510(k) Report

Devices descending from K053146

27 later devices reach Quickvue Influenza a + B Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121797BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company20126—
+1K120049BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company20126—
+1K112277BD Veritor (TM) System for Rapid Detection of Flu a+BBecton, Dickinson and Company2011201
+1K083746Biosign Flu a+BPrinceton BioMeditech Corp.201003
+1K092698Quickvue Influenza a+B TestQuidel Corp.200924—
+1K083278Avc a/H5N1 Flu TestArbor Vita Corportation20090—
+2K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd20232—
+2K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd201852
+2K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO20160—
+2K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO20169—
+2K152870BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson and Co.201510—
+2K152874BD Veritor System for the Rapid Detection of Flu A + B Laboratory kitBecton, Dickinson and Co.20151—
+2K151291BD Veritor (TM) System for the Rapid Detection of Flu A+BBecton, Dickinson and Company201511—
+2K151301BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company20152—
+2K133140BD Veritor System for the Rapid Detection of RSVBecton, Dickinson & CO20130—
+2K133138BD Veritor™ System Flu A+B AssayBecton, Dickinson & CO20133—
+2K132693BD Veritor™ System Flu A+B AssayBecton, Dickinson and Company20133—
+2K132692BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company201317—
+2K132259BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company201319—
+2K132256BD Veritor System for the Rapid Detection of Flu a+BBecton, Dickinson and Company20135—
+3K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd20231—
+3K191514CareStart Flu A&B PlusAccess Bio, Inc.20201—
+3K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Alere Scarborough, Inc.20172—
+4K252283Nano-Check Influenza A+B TestNano-Ditech Corporation20260—
+4K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.20250—
+4K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Alere Scarborough, Inc.20171—
+5K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderAlere Scarborough, Inc.20180—