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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 the device name listed in this FDA 510(k) record. The listed applicant is Luminex Corporation. It received FDA 510(k) clearance on 2016-12-23 under 510(k) 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. The listed applicant is Luminex Corporation. The 510(k) number is K162772.

When did ARIES GBS Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for ARIES GBS Assay?

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 GBS Assay?

The FDA product code for ARIES GBS Assay is NJR.

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.

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Related Devices (Code: NJR)

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.

K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsCepheidK203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheidK182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLCK181156Panther Fusion GBS AssayDiagenodeK173725NeuMoDx GBS AssayNeumodx Molecular, Inc.K173250Solana GBS AssayQuidel 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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