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FDA 510(k)

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

K-Number: K160161 · 2016-02-24

ApplicantBecton, Dickinson & CO
Decision Date2016-02-24
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 Becton, Dickinson & CO. It received FDA 510(k) clearance on 2016-02-24 under approval number K160161. 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 2016-02-24. It is manufactured by Becton, Dickinson & CO. The 510(k) number is K160161.

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 2016-02-24, under approval number K160161.

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 Becton, Dickinson & CO.

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 Becton, Dickinson & CO

K160164BD Veritor System for Rapid Detection of Flu A + B Labratory Kit

Related Devices (Code: PSZ)

K160164BD Veritor System for Rapid Detection of Flu A + B Labratory 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. K182001Acucy Influenza A&B Test with the Acucy SystemSEKISUI Diagnostics, LLC

Official Source

View on FDA Database →

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

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