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FDA 510(k)

Thermo Scientific Sensititre ARIS HiQ System

K-Number: K191914 · 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 the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2019-11-06 under 510(k) number K191914. 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. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K191914.

When did Thermo Scientific Sensititre ARIS HiQ System receive FDA 510(k) clearance?

Thermo Scientific Sensititre ARIS HiQ System received FDA 510(k) clearance on 2019-11-06, under 510(k) number K191914.

Who is the listed applicant for Thermo Scientific Sensititre ARIS HiQ System?

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Thermo Fisher Scientific as applicant

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Related Devices (Code: LRG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191918Thermo 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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