FDA 510(k)

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

K-Number: K160164 · 2016-02-25

Decision Date2016-02-25

Product CodePSZ

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

BD Veritor System for Rapid Detection of Flu A + B Labratory Kit is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K160164. 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 Labratory Kit?

BD Veritor System for Rapid Detection of Flu A + B Labratory Kit is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K160164.

When did BD Veritor System for Rapid Detection of Flu A + B Labratory Kit receive FDA 510(k) clearance?

BD Veritor System for Rapid Detection of Flu A + B Labratory Kit received FDA 510(k) clearance on 2016-02-25, under 510(k) number K160164.

Who is the listed applicant for BD Veritor System for Rapid Detection of Flu A + B Labratory Kit?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: PSZ)

K252283Nano-Check Influenza A+B TestNano-Ditech Corporation K250398Innovita Flu A/B Antigen Rapid TestInnovita (Tangshan) Biological Technology Co., Ltd.K241188Acucy® Influenza A&B Test with the Acucy® 2 SystemSEKISUI Diagnostics, LLC K232434BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived KitBd K223016BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived KitBd K192719Osom Ultra Plus Flu A&B Test KitSEKISUI 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.