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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 a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2016-06-30 under approval 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. It is manufactured by Luminex Corporation. The 510(k) number is K161495.

When was ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) approved by the FDA?

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 approval number K161495.

What company makes 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 manufactured by Luminex Corporation.

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.

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Other Devices by Luminex Corporation

K162772ARIES GBS Assay K161220ARIES® Flu A/B & RSV Assay 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 K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

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Related Devices (Code: OOI)

K160517ARIES SystemLuminex Corporation K170558revogeneGenepoc, Inc. K220480RevogeneMeridian Bioscience, Inc. K222779RevogeneMeridian Bioscience, Inc. K243922RevogeneMeridian Bioscience, 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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