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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(k) Number K040767
Device Name SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
Applicant
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Applicant Contact ANNETTE HELLIE
Correspondent
BECKMAN COULTER, INC.
200 SOUTH KRAEMER BLVD. W-110
BREA,  CA  92822
Correspondent Contact ANNETTE HELLIE
Regulation Number862.1475
Classification Product Code
LBS  
Date Received03/25/2004
Decision Date 06/07/2004
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
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