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FDA 510(k)

ARIES GBS Assay

K-Number: K162772 · 2016-12-23

ApplicantLuminex Corporation
Decision Date2016-12-23
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARIES GBS Assay is a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2016-12-23 under approval number K162772. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIES GBS Assay?

ARIES GBS Assay is a medical device that received FDA 510(k) clearance on 2016-12-23. It is manufactured by Luminex Corporation. The 510(k) number is K162772.

When was ARIES GBS Assay approved by the FDA?

ARIES GBS Assay received FDA 510(k) clearance on 2016-12-23, under approval number K162772.

What company makes ARIES GBS Assay?

ARIES GBS Assay is manufactured by Luminex Corporation.

What is the FDA product code for ARIES GBS Assay?

The FDA product code for ARIES GBS Assay is NJR.

Other Devices by Luminex Corporation

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 K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

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Related Devices (Code: NJR)

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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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