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FDA 510(k)

Thermo Scientific Sensititre ARIS HiQ System

K-Number: K191918 · 2019-11-06

ApplicantThermo Fisher Scientific
Decision Date2019-11-06
Product CodeLRG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Thermo Scientific Sensititre ARIS HiQ System is a medical device manufactured by Thermo Fisher Scientific. It received FDA 510(k) clearance on 2019-11-06 under approval number K191918. The device is classified under product code LRG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Thermo Scientific Sensititre ARIS HiQ System?

Thermo Scientific Sensititre ARIS HiQ System is a medical device that received FDA 510(k) clearance on 2019-11-06. It is manufactured by Thermo Fisher Scientific. The 510(k) number is K191918.

When was Thermo Scientific Sensititre ARIS HiQ System approved by the FDA?

Thermo Scientific Sensititre ARIS HiQ System received FDA 510(k) clearance on 2019-11-06, under approval number K191918.

What company makes Thermo Scientific Sensititre ARIS HiQ System?

Thermo Scientific Sensititre ARIS HiQ System is manufactured by Thermo Fisher Scientific.

What is the FDA product code for Thermo Scientific Sensititre ARIS HiQ System?

The FDA product code for Thermo Scientific Sensititre ARIS HiQ System is LRG.

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Related PubMed Literature

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Related Devices (Code: LRG)

K191914Thermo Scientific Sensititre ARIS HiQ SystemThermo Fisher Scientific

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.

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