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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K131185
Device Name ANA SCREEN ELISA (IGG)
Applicant
Euroimmun US
1100 The American Rd.
Morris Plains,  NJ  07950
Applicant Contact MICHAEL LOCKE
Correspondent
Euroimmun US
1100 The American Rd.
Morris Plains,  NJ  07950
Correspondent Contact MICHAEL LOCKE
Regulation Number866.5100
Classification Product Code
LJM  
Date Received04/26/2013
Decision Date 07/15/2013
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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