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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K070552
Device Name DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
MS 514
NEWARK,  DE  19714
Applicant Contact LORRAINE H PIESTRAK
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
MS 514
NEWARK,  DE  19714
Correspondent Contact LORRAINE H PIESTRAK
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
DBF  
Date Received02/27/2007
Decision Date 04/30/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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