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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
510(k) Number K191914
Device Name Thermo Scientific Sensititre ARIS HiQ System
Applicant
Thermo Fisher Scientific
1 Thermo Fisher Way
Oakwood Village,  OH  44014
Applicant Contact Cynthia Knapp
Correspondent
Thermo Fisher Scientific
1 Thermo Fisher Way
Oakwood Village,  OH  44014
Correspondent Contact Cynthia Knapp
Regulation Number866.1640
Classification Product Code
LRG  
Date Received07/17/2019
Decision Date 11/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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