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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
510(k) Number K153117
Device Name AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
Applicant
Aesku Systems GmbH&Co.Kg
Mikroforum Ring 3
Wendelsheim,  DE 55234
Applicant Contact TOM STECKLUM
Correspondent
Aesku Systems GmbH&Co.Kg
95 Linden St.
Suite 4
Oakland,  CA  94607
Correspondent Contact Rose Rainwater
Regulation Number866.5100
Classification Product Code
DHN  
Subsequent Product Code
PIV  
Date Received10/28/2015
Decision Date 07/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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