ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)— 510(k) K161495
Substantially EquivalentLuminex Corporation
FDA 510(k) clearance K161495 for ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), Substantially Equivalent on 2016-06-30. Applicant: Luminex Corporation. Device class: 2.
Clearance details
- Applicant
- Luminex Corporation
- Product code
- Code OOI
- Device class
- Class 2
- Regulation
- 21 CFR 862.2570
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Austin, TX, US
Recent devices under product code OOI
view allMore clearances from Luminex Corporation
view allAdverse events under product code OOI
product code OOI- Malfunction
- 2,506
- Other
- 3
- Total
- 2,509
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 K161495
K-number listed on FDA's recall record- Z-0553-2022 — ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
- Z-0498-2022 — ARIES HSV 1&2 Assay, Part Number/REF 50-10017
- Z-2283-2019 — ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
- 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 170512-017
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161495.
Data sourced from openFDA. This site is unofficial and independent of the FDA.