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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K061719
Device Name DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR; MODELS K1167, KC212
Applicant
Dade Behring, Inc.
P.O. Box 6101, Ms 514
Newark,  DE  19714 -6101
Applicant Contact GEORGE W PLUMMER
Correspondent
Dade Behring, Inc.
P.O. Box 6101, Ms 514
Newark,  DE  19714 -6101
Correspondent Contact GEORGE W PLUMMER
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
JIT  
Date Received06/19/2006
Decision Date 08/25/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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