ARIES GBS Assay— 510(k) K162772

Substantially Equivalent

Luminex Corporation

FDA 510(k) clearance K162772 for ARIES GBS Assay, Substantially Equivalent on 2016-12-23. Applicant: Luminex Corporation. Device class: 1.

Clearance details

Applicant: Luminex Corporation
Product code: Code NJR
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 2016-10-03
Decision date: 2016-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NJR

K222638 — Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems2023-09-27
K203429 — Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System2022-05-09
K182467 — Simplexa GBS Direct, Simplexa GBS Positive Control Pack2018-11-07
K181156 — Panther Fusion GBS Assay2018-07-27
K173725 — NeuMoDx GBS Assay2018-06-26

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Recalls naming K162772

K-number listed on FDA's recall record

Z-2285-2019 — ARIES GBS Assay , REF 50-10021, UDI # 00840487100165Class II·Ongoing·Luminex Corporation·20190220
Z-2292-2019 — Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017Class II·Terminated·Luminex Corporation·20180629
Z-2094-2017 — ARIES System and ARIES M1 SystemClass II·Terminated·Luminex Corporation·20170419

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K162772.

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