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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K172461
Device Name AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
Applicant
Aesku.Diagnostics GmbH & Co. KG
Mikro-Forum-Ring 2
Wendelsheim,  DE 55234
Applicant Contact Sandra Reuter
Correspondent
Aesku.Diagnostics GmbH & Co. KG
Mikro-Forum-Ring 2
Wendelsheim,  DE 55234
Correspondent Contact Sandra Reuter
Regulation Number866.5660
Classification Product Code
MOB  
Date Received08/14/2017
Decision Date 03/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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