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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, Hdl
510(k) Number K903094
Device Name STAT TEST HDL/CHOLESTEROL TEST KIT
Applicant
Diagnostic Resources, Inc.
375 Central Ave.
Bohemia,  NY  11716
Applicant Contact RINALDO PAGNUCCO
Correspondent
Diagnostic Resources, Inc.
375 Central Ave.
Bohemia,  NY  11716
Correspondent Contact RINALDO PAGNUCCO
Regulation Number862.1475
Classification Product Code
LBR  
Date Received07/13/1990
Decision Date 08/29/1990
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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