DeviceClearance

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. Device class: 2.

Clearance details

Applicant
Luminex Corporation
Product code
Code OCC
Device class
Class 2
Regulation
21 CFR 866.3980
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Austin, TX, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OCC

product code OCC
Death
3
Malfunction
706
Total
709

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

Recalls naming K161220

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161220.

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