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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 K013152
Device Name ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS
Applicant
Elan Holdings, Inc.
1075 W. Lambert Rd.
Suite D
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Elan Holdings, Inc.
1075 W. Lambert Rd.
Suite D
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1475
Classification Product Code
LBS  
Date Received09/20/2001
Decision Date 11/09/2001
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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