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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transferrin, Antigen, Antiserum, Control
510(k) Number K063322
Device Name DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H
Applicant
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
Dade Behring, Inc.
Glasgow Site, P.O. Box 6101
Newark,  DE  19714
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number866.5880
Classification Product Code
DDG  
Subsequent Product Codes
JIX   JJY  
Date Received11/03/2006
Decision Date 01/24/2007
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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