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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Lipoproteins
510(k) Number K073072
Device Name DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B
Applicant
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714 -6101
Applicant Contact PAMELA A JURGA
Correspondent
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714 -6101
Correspondent Contact PAMELA A JURGA
Regulation Number862.1475
Classification Product Code
JHM  
Date Received10/31/2007
Decision Date 02/21/2008
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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