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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 K060628
Device Name DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR
Applicant
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500, Ms 514 P.O.Box 6101
Newark,  DE  19714
Applicant Contact GEORGE M PLUMMER
Correspondent
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500, Ms 514 P.O.Box 6101
Newark,  DE  19714
Correspondent Contact GEORGE M PLUMMER
Regulation Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
JIS  
Date Received03/09/2006
Decision Date 04/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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