ARIES® Flu A/B & RSV Assay— 510(k) K161220

Substantially Equivalent

Luminex Corporation

FDA 510(k) clearance K161220 for ARIES® Flu A/B & RSV Assay, Substantially Equivalent on 2016-08-02. Applicant: Luminex Corporation.

Clearance details

Applicant: Luminex Corporation
Product code: Code OCC
Advisory panel: Microbiology
Date received: 2016-04-29
Decision date: 2016-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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