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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Rnp Antibody, Antigen And Control
510(k) Number K123261
Device Name EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
Applicant
Euroimmun US
1100 The American Rd.
Morris Plains,  NJ  07950
Applicant Contact KATHRYN KOHL
Correspondent
Euroimmun US
1100 The American Rd.
Morris Plains,  NJ  07950
Correspondent Contact KATHRYN KOHL
Regulation Number866.5100
Classification Product Code
LKO  
Subsequent Product Codes
LJM   LKP   LLL   MQA  
Date Received10/18/2012
Decision Date 06/12/2013
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
Predetermined Change
Control Plan Authorized		 No
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