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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 K911661
Device Name ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
Applicant
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Applicant Contact ERIC S HOY
Correspondent
Immuno Concepts, Inc.
9779-D Business Park Dr.
Sacramento,  CA  95827
Correspondent Contact ERIC S HOY
Regulation Number866.5660
Classification Product Code
MID  
Date Received04/12/1991
Decision Date 12/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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