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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 K063508
Device Name DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PROTEIN 2 CALIBRATOR AND CONTROL L, H; PROTEIN 3 CALIBRATOR AN
Original Applicant
DADE BEHRING, INC.
p.o. box 6101
newark,,  DE  19714
Original Contact helen m lee
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Code
JJY  
Date Received11/20/2006
Decision Date 01/23/2007
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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