ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit— 510(k) K171441

Substantially Equivalent

Luminex Corporation

FDA 510(k) clearance K171441 for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit, Substantially Equivalent on 2017-07-21. Applicant: Luminex Corporation. Device class: 2.

Clearance details

Applicant: Luminex Corporation
Product code: Code OZN
Device class: Class 2
Regulation: 21 CFR 866.3130
Advisory panel: Microbiology
Date received: 2017-05-16
Decision date: 2017-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OZN

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Recalls naming K171441

K-number listed on FDA's recall record

Z-2287-2019 — ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059Class II·Ongoing·Luminex Corporation·20190220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171441.

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