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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 K061750
Device Name DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
Original Applicant
DADE BEHRING, INC.
500 gbc dr, mailstop 514
newark,  DE  19714 6101
Original Contact victor m carrio
Regulation Number862.1150
Classification Product Code
JIX  
Date Received06/21/2006
Decision Date 08/11/2006
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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