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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody, Antigen And Control
510(k) Number K072393
Device Name ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
Applicant
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Applicant Contact MARTIN R MANN
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Correspondent Contact MARTIN R MANN
Regulation Number866.5100
Classification Product Code
LSW  
Subsequent Product Code
JJY  
Date Received08/27/2007
Decision Date 12/07/2007
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
Recalls CDRH Recalls
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