510(k) Report

Devices descending from K160161

9 later devices reach BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd20232—
+1K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBd201852
+1K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Alere Scarborough, Inc.20172—
+2K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd20231—
+2K191514CareStart Flu A&B PlusAccess Bio, Inc.20201—
+2K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card…Alere Scarborough, Inc.20171—
+3K252283Nano-Check Influenza A+B TestNano-Ditech Corporation20260—
+3K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.20250—
+3K181853Alere BinaxNOW Influenza A & B Card 2, Alere ReaderAlere Scarborough, Inc.20180—