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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyclosporine
510(k) Number K062236
Device Name DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE
Applicant
Dade Behring, Inc.
P.O. Box Box 6101, M/S 514
Newark,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
Dade Behring, Inc.
P.O. Box Box 6101, M/S 514
Newark,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.1235
Classification Product Code
MKW  
Date Received08/02/2006
Decision Date 08/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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