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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 K895139
Device Name CLINISTAT HDL CHOLESTEROL REAGENT TEST
Applicant
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Applicant Contact ROSANNE SAVOL
Correspondent
Heraeus Kulzer, Inc.
Diagnostics Division
P.O. Box 70
Elkhart,  IN  46515
Correspondent Contact ROSANNE SAVOL
Regulation Number862.1475
Classification Product Code
LBS  
Date Received08/16/1989
Decision Date 12/27/1989
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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