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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Gliadin
510(k) Number K132082
Device Name AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
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 Number866.5750
Classification Product Code
MST  
Date Received07/05/2013
Decision Date 12/05/2013
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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