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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 K100010
Device Name HDL CHOLESTEROL (HDLX) ASSAY
Applicant
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Mail Stop E2 Se08
Brea,  CA  92821
Applicant Contact Yvette Lloyd
Correspondent
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Mail Stop E2 Se08
Brea,  CA  92821
Correspondent Contact Yvette Lloyd
Regulation Number862.1475
Classification Product Code
LBS  
Date Received01/04/2010
Decision Date 05/14/2010
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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