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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 K981224
Device Name DIRECT HDL
Applicant
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING,  TX  75038
Applicant Contact MARK LITTLEFIELD
Correspondent
ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING,  TX  75038
Correspondent Contact MARK LITTLEFIELD
Regulation Number862.1475
Classification Product Code
LBS  
Date Received04/03/1998
Decision Date 08/03/1998
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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