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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
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