K232434

BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit

510(k) number
K232434
Device name
BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit
Applicant
Bd MD · US
Product code
PSZ — Devices Detecting Influenza A, B, And C Virus Antige
Decision date
2023-12-05
Date received
2023-08-11
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain

Also available from FDA: K232434.pdf

Official FDA record: K232434
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.