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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 K091859
Device Name AESKU PR3
Applicant
Aesku Diagnostics
Mikroforum Ring 2
Wendelsheim, Rheinland,  DE D-55234
Applicant Contact SASCHA PFEIFFER
Correspondent
Aesku Diagnostics
Mikroforum Ring 2
Wendelsheim, Rheinland,  DE D-55234
Correspondent Contact SASCHA PFEIFFER
Regulation Number866.5660
Classification Product Code
MOB  
Date Received06/19/2009
Decision Date 06/03/2010
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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