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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 K030929
Device Name ANA DETECT
Applicant
Orgentec Diagnostika GmbH
8201 Central Ave. NE
Suite P
Minneapolis,  MN  55432
Applicant Contact MICHAEL H FOLEY
Correspondent
Orgentec Diagnostika GmbH
8201 Central Ave. NE
Suite P
Minneapolis,  MN  55432
Correspondent Contact MICHAEL H FOLEY
Regulation Number866.5100
Classification Product Code
LJM  
Subsequent Product Code
LRM  
Date Received03/24/2003
Decision Date 05/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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