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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K062191
Device Name DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516
Applicant
Dade Behring, Inc.
500 Gbc Dr.,
M/S 514, P.O. Box 6101
Newark,  DE  19714
Applicant Contact VICTOR M CARRIO
Correspondent
Dade Behring, Inc.
500 Gbc Dr.,
M/S 514, P.O. Box 6101
Newark,  DE  19714
Correspondent Contact VICTOR M CARRIO
Regulation Number862.3280
Classification Product Code
DIF  
Date Received07/31/2006
Decision Date 08/21/2006
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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