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FDA 510(k)

ARIES System

K-Number: K160517 · 2016-04-12

ApplicantLuminex Corporation
Decision Date2016-04-12
Product CodeOOI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARIES System is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2016-04-12 under 510(k) number K160517. The device is classified under product code OOI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIES System?

ARIES System is a medical device that received FDA 510(k) clearance on 2016-04-12. The listed applicant is Luminex Corporation. The 510(k) number is K160517.

When did ARIES System receive FDA 510(k) clearance?

ARIES System received FDA 510(k) clearance on 2016-04-12, under 510(k) number K160517.

Who is the listed applicant for ARIES System?

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 System?

The FDA product code for ARIES System is OOI.

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: OOI)

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.

K243922RevogeneMeridian Bioscience, Inc.K222779RevogeneMeridian Bioscience, Inc.K220480RevogeneMeridian Bioscience, Inc.K170558revogeneGenepoc, Inc.K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)Luminex Corporation

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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