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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 K061503
Device Name DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)
Applicant
Dade Behring, Inc.
P.O. Box 6101, Ms 514
Newark,  DE  19714 -6101
Applicant Contact ANDREA M TASKER
Correspondent
Dade Behring, Inc.
P.O. Box 6101, Ms 514
Newark,  DE  19714 -6101
Correspondent Contact ANDREA M TASKER
Regulation Number862.3200
Classification Product Code
DLJ  
Date Received06/01/2006
Decision Date 06/22/2006
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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