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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 K971190
Device Name N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR
Applicant
Genzyme Corp.
One Kendall Square
Cambridge,  MA  02139
Applicant Contact Nancy E Isaac
Correspondent
Genzyme Corp.
One Kendall Square
Cambridge,  MA  02139
Correspondent Contact Nancy E Isaac
Regulation Number862.1475
Classification Product Code
LBS  
Subsequent Product Code
JIS  
Date Received03/31/1997
Decision Date 06/16/1997
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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