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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Albumin, Antigen, Antiserum, Control
510(k) Number K033525
Device Name DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114
Applicant
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714
Applicant Contact RICHARD M VAUGHT
Correspondent
Dade Behring, Inc.
Glasgow Business Community;
Bldg. 500 Mail Box 514
P.O. Box 6101, Newark,  DE  19714
Correspondent Contact RICHARD M VAUGHT
Regulation Number866.5040
Classification Product Code
DCF  
Subsequent Product Code
JIT  
Date Received11/07/2003
Decision Date 01/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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
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