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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
Original Applicant
DADE BEHRING, INC.
p.o. box 6101
newark,,  DE  19714
Original 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 (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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