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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Drug Specific
510(k) Number K062199
Device Name DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)
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 Number862.3200
Classification Product Code
DLJ  
Date Received08/01/2006
Decision Date 09/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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