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FDA 510(k)

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

K-Number: K161495 · 2016-06-30

ApplicantLuminex Corporation
Decision Date2016-06-30
Product CodeOOI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2016-06-30 under 510(k) number K161495. 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 MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)?

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) is a medical device that received FDA 510(k) clearance on 2016-06-30. The listed applicant is Luminex Corporation. The 510(k) number is K161495.

When did ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) receive FDA 510(k) clearance?

ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) received FDA 510(k) clearance on 2016-06-30, under 510(k) number K161495.

Who is the listed applicant for ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)?

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 MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)?

The FDA product code for ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) 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.K160517ARIES SystemLuminex 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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