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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
Predetermined Change
Control Plan Authorized		 No
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