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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 K072435
Device Name DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
Original Applicant
DADE BEHRING, INC.
p.o. box 6101
newark,  DE  19714
Original Contact kathleen ennis
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Code
JJY  
Date Received08/30/2007
Decision Date 10/17/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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