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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 the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2017-05-02 under 510(k) 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. The listed applicant is Luminex Corporation. The 510(k) number is K163626.

When did ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit?

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 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 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.

K253722LIAISON PLEX Gastrointestinal Flex AssayK243490LIAISON PLEX Gram-Positive Blood Culture AssayK243013LIAISON PLEX Gram-Negative Blood Culture AssayK240627LIAISON PLEX Yeast Blood Culture AssayK233410LIAISON PLEX Respiratory Flex AssayK191742ARIES MRSA Assay

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Related Devices (Code: OZZ)

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.

K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.K183223Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK181029Solana Bordetella Complete AssayQuidel CorporationK170284Great Basin Bordetella Direct TestGreat Basin Scientific, 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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