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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K102673
Device Name RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
Applicant
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Applicant Contact MARTIN M MANN
Correspondent
Phadia US, Inc.
4169 Commercial Ave.
Portage,  MI  49002
Correspondent Contact MARTIN M MANN
Regulation Number866.5775
Classification Product Code
DHR  
Subsequent Product Code
JJY  
Date Received09/16/2010
Decision Date 09/30/2011
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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