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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, Beta-2-Microglobulin Immunological
510(k) Number K063272
Device Name DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
Applicant
Dade Behring, Inc.
P.O. Box 6101
Newark,,  DE  19714
Applicant Contact KATHLEEN DRAY-LYONS
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Newark,,  DE  19714
Correspondent Contact KATHLEEN DRAY-LYONS
Regulation Number866.5630
Classification Product Code
JZG  
Subsequent Product Codes
JIX   JJY  
Date Received10/30/2006
Decision Date 01/26/2007
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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