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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 K061390
Device Name DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
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 Received05/18/2006
Decision Date 07/05/2006
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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