Cleared Traditional

Thermo Scientific Sensititre ARIS HiQ System

K191914 · Thermo Fisher Scientific · Microbiology
Nov 2019
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K191914 is an FDA 510(k) clearance for the Thermo Scientific Sensititre ARIS HiQ System, a Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (Class II — Special Controls, product code LRG), submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on November 6, 2019, 112 days after receiving the submission on July 17, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K191914 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2019
Decision Date November 06, 2019
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LRG — Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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