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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 (SE)
Classification Advisory Committee Immunology
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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