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FDA 510(k)

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

K-Number: K172402 · 2017-10-30

ApplicantLuminex Corporation
Decision Date2017-10-30
Product CodePGX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2017-10-30 under approval number K172402. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is a medical device that received FDA 510(k) clearance on 2017-10-30. It is manufactured by Luminex Corporation. The 510(k) number is K172402.

When was ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit approved by the FDA?

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit received FDA 510(k) clearance on 2017-10-30, under approval number K172402.

What company makes ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is manufactured by Luminex Corporation.

What is the FDA product code for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit?

The FDA product code for ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit is PGX.

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Related PubMed Literature

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Other Devices by Luminex Corporation

K162772ARIES GBS Assay 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 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

View all 12 devices →

Related Devices (Code: PGX)

K162274Solana Strep Complete AssayQuidel Corporation K172126Xpert Xpress Strep ACepheid K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc. K173398Xpert Xpress Strep ACepheid K183366GenePOC Strep AGenepoc, Inc. K201269Accula Strep A TestMesa Biotech, 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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