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FDA 510(k)

QUICK VUE INFLUENZA

K-Number: K131599 · 2013-07-05

ApplicantQuidel Corporation
Decision Date2013-07-05
Product CodeGNX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QUICK VUE INFLUENZA is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2013-07-05 under 510(k) number K131599. The device is classified under product code GNX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICK VUE INFLUENZA?

QUICK VUE INFLUENZA is a medical device that received FDA 510(k) clearance on 2013-07-05. The listed applicant is Quidel Corporation. The 510(k) number is K131599.

When did QUICK VUE INFLUENZA receive FDA 510(k) clearance?

QUICK VUE INFLUENZA received FDA 510(k) clearance on 2013-07-05, under 510(k) number K131599.

Who is the listed applicant for QUICK VUE INFLUENZA?

The FDA 510(k) record lists Quidel Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUICK VUE INFLUENZA?

The FDA product code for QUICK VUE INFLUENZA is GNX.

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Related Devices (Code: GNX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K133411ALERE BINAXNOW INFLUENZA A & B CARDAlere Scarborough, Inc D/B/A Binax, Inc.K132352SAS FLUALERT A & B, SAS INFLUENZA A TESTSa Scientific , Ltd.K131804REMEL XPECT FLU A&BRemel, Inc.K131606SOFIA INFLUENZA A+B FIAQuidel Corp.K131619QUICKVUE INFLUENZA A+BQuidel Corp.K123182OSOM INFLUENZA A&B TEST MODEL 190SEKISUI 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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