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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 K840677
Device Name HDL EZ-TZ3 CHOLESTEROL REAGENT KIT
Applicant
Preventive Diagnostics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Preventive Diagnostics Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1475
Classification Product Code
LBS  
Date Received02/15/1984
Decision Date 04/13/1984
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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