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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody, Antigen And Control
510(k) Number K172348
Device Name AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
Applicant
Aesku.Diagnostics GmbH & Co. KG
Mikro-Forum-Ring 2
Wendeslheim,  DE 55234
Applicant Contact Sandra Reuter
Correspondent
Aesku.Diagnostics GmbH & Co. KG
Mikro-Forum-Ring 2
Wendeslheim,  DE 55234
Correspondent Contact Sandra Reuter
Regulation Number866.5100
Classification Product Code
LSW  
Subsequent Product Code
DHN  
Date Received08/03/2017
Decision Date 02/16/2018
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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