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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K073055
Device Name DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
Applicant
Dade Behring, Inc.
P.O. Box 6101
Ms 514
Newark,  DE  19714
Applicant Contact VICTOR M CARRIO
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Ms 514
Newark,  DE  19714
Correspondent Contact VICTOR M CARRIO
Regulation Number862.1225
Classification Product Code
JFY  
Date Received10/30/2007
Decision Date 01/03/2008
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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