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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K053104
Device Name DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
Applicant
Dade Behring, Inc.
Glasgow Business Community
P.O. Box 6101 Bldg. 500
Newark,  DE  19714 -6101
Applicant Contact ANDREA M TASKER
Correspondent
Dade Behring, Inc.
Glasgow Business Community
P.O. Box 6101 Bldg. 500
Newark,  DE  19714 -6101
Correspondent Contact ANDREA M TASKER
Regulation Number862.1150
Classification Product Code
JIS  
Date Received11/04/2005
Decision Date 12/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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