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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 K081251
Device Name MODIFICATION TO AESKULISA DS DNA G
Applicant
Aesku Diagnostics
Mikroforum Ring 2
Wendelsheim, Rheinland,  DE D-55234
Applicant Contact SASCHA PFEIFFER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number866.5100
Classification Product Code
LSW  
Date Received05/02/2008
Decision Date 05/13/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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