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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K061793
Device Name DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
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 Number862.1410
Classification Product Code
JIY  
Subsequent Product Code
JIT  
Date Received06/26/2006
Decision Date 08/07/2006
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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