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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K020724
Device Name DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131
Applicant
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500, Ms 514 P.O.Box 6101
Newark,  DE  19714 -6101
Applicant Contact RICHARD M VAUGHT
Correspondent
Dade Behring, Inc.
Glasgow Business Community
Bldg. 500, Ms 514 P.O.Box 6101
Newark,  DE  19714 -6101
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.1475
Classification Product Code
MRR  
Date Received03/06/2002
Decision Date 05/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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