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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 K071247
Device Name N LATEX RF KIT
Applicant
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714
Applicant Contact HELEN LEE
Correspondent
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714
Correspondent Contact HELEN LEE
Regulation Number866.5775
Classification Product Code
DHR  
Date Received05/04/2007
Decision Date 08/08/2007
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
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