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FDA 510(k)

ARIES® Flu A/B & RSV Assay

K-Number: K161220 · 2016-08-02

ApplicantLuminex Corporation
Decision Date2016-08-02
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARIES® Flu A/B & RSV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2016-08-02 under 510(k) number K161220. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIES® Flu A/B & RSV Assay?

ARIES® Flu A/B & RSV Assay is a medical device that received FDA 510(k) clearance on 2016-08-02. The listed applicant is Luminex Corporation. The 510(k) number is K161220.

When did ARIES® Flu A/B & RSV Assay receive FDA 510(k) clearance?

ARIES® Flu A/B & RSV Assay received FDA 510(k) clearance on 2016-08-02, under 510(k) number K161220.

Who is the listed applicant for ARIES® Flu A/B & RSV Assay?

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

What is the FDA product code for ARIES® Flu A/B & RSV Assay?

The FDA product code for ARIES® Flu A/B & RSV Assay is OCC.

Other records listing Luminex Corporation as applicant

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.

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Related Devices (Code: OCC)

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.

K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

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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