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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 K113020
Device Name IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
Original Applicant
IMMCO DIAGNOSTICS, INC.
60 pineview dr.
buffalo,  NY  14228 -2120
Original Contact kevin j lawson
Regulation Number866.5660
Classification Product Code
MID  
Date Received10/11/2011
Decision Date 10/25/2012
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
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