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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 K112996
Device Name EUROIMMUN ANTI-ENA POOL ELISA (IGG)
Original Applicant
EUROIMMUN US
1100 the american road
morris plains,  NJ  07950
Original Contact kathryn kohl
Regulation Number866.5100
Classification Product Code
LLL  
Date Received10/07/2011
Decision Date 04/09/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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