510(k) Report

Devices descending from K180438

5 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—
+1K191514CareStart Flu A&B PlusAccess Bio, Inc.20201—
+2K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.20250—
+2K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd20231—
+3K252283Nano-Check Influenza A+B TestNano-Ditech Corporation20260—