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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
510(k) Number K051492
Device Name AESKULISA ASCA A
Applicant
Aesku, Inc.
8880 Northwest 18th Ter.
Miami,  FL  33172
Applicant Contact STANLEY AMMONS
Correspondent
Aesku, Inc.
8880 Northwest 18th Ter.
Miami,  FL  33172
Correspondent Contact STANLEY AMMONS
Regulation Number866.5785
Classification Product Code
NBT  
Date Received06/06/2005
Decision Date 11/14/2005
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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