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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 K051962
Device Name ULTRA HDL
Applicant
Abbott Laboratories
Dept. 09va Lc-2
1920 Hurd Dr.
Irving,  TX  75038
Applicant Contact LINDA MORRIS
Correspondent
Abbott Laboratories
Dept. 09va Lc-2
1920 Hurd Dr.
Irving,  TX  75038
Correspondent Contact LINDA MORRIS
Regulation Number862.1475
Classification Product Code
LBS  
Date Received07/19/2005
Decision Date 08/25/2005
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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