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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K032469
Device Name AESKULISA ANA 8PRO
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 Number866.5100
Classification Product Code
LLL  
Subsequent Product Code
LJM  
Date Received08/11/2003
Decision Date 12/16/2003
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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