ARIES System
K-Number: K160517 · 2016-04-12
ApplicantLuminex Corporation
Decision Date2016-04-12
Product CodeOOI
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
ARIES System is a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2016-04-12 under approval number K160517. The device is classified under product code OOI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARIES System?
ARIES System is a medical device that received FDA 510(k) clearance on 2016-04-12. It is manufactured by Luminex Corporation. The 510(k) number is K160517.
When was ARIES System approved by the FDA?
ARIES System received FDA 510(k) clearance on 2016-04-12, under approval number K160517.
What company makes ARIES System?
ARIES System is manufactured by Luminex Corporation.
What is the FDA product code for ARIES System?
The FDA product code for ARIES System is OOI.
Other Devices by Luminex Corporation
K162772ARIES GBS Assay
K161220ARIES® Flu A/B & RSV Assay
K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit
K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
Related Devices (Code: OOI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.