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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K061990
Device Name DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE; PROTEIN 3 CALIBRATOR; PROTEIN 3 CONTROL
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 Number866.5040
Classification Product Code
DCF  
Subsequent Product Codes
JIT   JJY  
Date Received07/13/2006
Decision Date 09/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
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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