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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 K060266
Device Name DIMENSION IRON CALIBRATOR
Applicant
DADE BEHRING, INC.
P.O. BOX 6101 BUILDING 500
GLASGOW BUSINESS COMMUNITY
NEWARK,,  DE  19714
Applicant Contact ANDREA M TASKER
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101 BUILDING 500
GLASGOW BUSINESS COMMUNITY
NEWARK,,  DE  19714
Correspondent Contact ANDREA M TASKER
Regulation Number862.1150
Classification Product Code
JIS  
Date Received02/01/2006
Decision Date 03/09/2006
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
Recalls CDRH Recalls
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