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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 K801726
Device Name HDL CHOLESTEROL TEST KIT
Applicant
Mallinckrodt Critical Care
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mallinckrodt Critical Care
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1475
Classification Product Code
LBS  
Date Received07/24/1980
Decision Date 09/09/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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