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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 K061251
Device Name DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
Applicant
DADE BEHRING, INC.
BLDG 500; M.S. 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact LORRAINE H PIESTRAK
Correspondent
DADE BEHRING, INC.
BLDG 500; M.S. 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.1150
Classification Product Code
JIS  
Date Received05/04/2006
Decision Date 05/31/2006
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
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