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FDA 510(k)

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

K-Number: K163626 · 2017-05-02

ApplicantLuminex Corporation
Decision Date2017-05-02
Product CodeOZZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit is a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2017-05-02 under approval number K163626. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit?

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit is a medical device that received FDA 510(k) clearance on 2017-05-02. It is manufactured by Luminex Corporation. The 510(k) number is K163626.

When was ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit approved by the FDA?

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit received FDA 510(k) clearance on 2017-05-02, under approval number K163626.

What company makes ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit?

ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit is manufactured by Luminex Corporation.

What is the FDA product code for ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit?

The FDA product code for ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit is OZZ.

Other Devices by Luminex Corporation

K162772ARIES GBS Assay K161220ARIES® Flu A/B & RSV Assay K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) K160517ARIES System K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

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Related Devices (Code: OZZ)

K170284Great Basin Bordetella Direct TestGreat Basin Scientific, Inc. K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLC K181029Solana Bordetella Complete AssayQuidel Corporation K243753cobas liat Bordetella panel nucleic acid testRoche 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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