FDA 510(k)

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

K-Number: K232434 · 2023-12-05

ApplicantBd

Decision Date2023-12-05

Product CodePSZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit is a medical device manufactured by Bd. It received FDA 510(k) clearance on 2023-12-05 under approval number K232434. The device is classified under product code PSZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit?

BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit is a medical device that received FDA 510(k) clearance on 2023-12-05. It is manufactured by Bd. The 510(k) number is K232434.

When was BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit approved by the FDA?

BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit received FDA 510(k) clearance on 2023-12-05, under approval number K232434.

What company makes BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit?

BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit is manufactured by Bd.

What is the FDA product code for BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit?

The FDA product code for BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit is PSZ.

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Related PubMed Literature

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Other Devices by Bd

K180438BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit K221504BD Surgiphor Antimicrobial Irrigation System K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit K240257Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit K253445BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120)

Related Devices (Code: PSZ)

K160164BD Veritor System for Rapid Detection of Flu A + B Labratory KitBecton, Dickinson & CO K160161BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitBecton, Dickinson & CO K153012Sofia Influenza A+B FIAQuidel Corporation K173502Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc. K162438Sofia Influenza A+B FIA on Sofia 2Quidel Corporation K162642Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab KitAlere Scarborough, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.