ARIES System— 510(k) K160517

Substantially Equivalent

Luminex Corporation

FDA 510(k) clearance K160517 for ARIES System, Substantially Equivalent on 2016-04-12. Applicant: Luminex Corporation.

Clearance details

Applicant: Luminex Corporation
Product code: Code OOI
Advisory panel: Clinical Chemistry
Date received: 2016-02-24
Decision date: 2016-04-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OOI

product code OOI

Malfunction: 2,506
Other: 3
Total: 2,509

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.