Clearance Summary
ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit received FDA 510(k) clearance under submission number K171441, sponsored by Luminex Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2017-07-21.
- Submission: K171441
- Applicant / Sponsor: Luminex Corporation
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3130
- Decision date: 2017-07-21
Classification & Regulation
This clearance is catalogued under FDA product code OZN and 21 CFR 866.3130, within the Microbiology review panel as a Class II device.