ARIES MRSA Assay— 510(k) K191742

Substantially Equivalent

Luminex Corporation

FDA 510(k) clearance K191742 for ARIES MRSA Assay, Substantially Equivalent on 2019-09-25. Applicant: Luminex Corporation. Device class: 2.

Clearance details

Applicant: Luminex Corporation
Product code: Code NQX
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 2019-07-01
Decision date: 2019-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.