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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Anticardiolipin Immunological
510(k) Number K040463
Device Name AESKULISA CARDIOLIPIN AGM
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 Number866.5660
Classification Product Code
MID  
Date Received02/23/2004
Decision Date 05/12/2004
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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