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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K062035
Device Name DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRATOR AND 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 Number862.1150
Classification Product Code
JIX  
Subsequent Product Codes
DHR   JJY  
Date Received07/19/2006
Decision Date 10/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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