Thermo Scientific Sensititre ARIS HiQ System

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

Thermo Fisher Scientific

The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Thermo Scientific Sensititre Aris Hiq System.

Pre-market Notification Details

Device IDK191918
501k NumberK191918
Device Name:Thermo Scientific Sensititre ARIS HiQ System
ClassificationInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village,  OH  44014 6
ContactCynthia Knapp
CorrespondentCynthia Knapp
Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village,  OH  44014 6
Product CodeLRG  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
501k Review PanelMicrobiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-18
Decision Date2019-11-06

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