Clearance Summary
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) received FDA 510(k) clearance under submission number K161495, sponsored by Luminex Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2016-06-30.
- Submission: K161495
- Applicant / Sponsor: Luminex Corporation
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.2570
- Decision date: 2016-06-30
Classification & Regulation
This clearance is catalogued under FDA product code OOI and 21 CFR 862.2570, within the Clinical Chemistry review panel as a Class II device.