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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 K061218
Device Name DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,  DE  19714
Applicant Contact VICTOR M CARRIO
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
NEWARK,  DE  19714
Correspondent Contact VICTOR M CARRIO
Regulation Number862.1150
Classification Product Code
JIX  
Date Received05/01/2006
Decision Date 06/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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