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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 K971573
Device Name N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
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
LBR  
Subsequent Product Codes
JIS   JIX  
Date Received04/30/1997
Decision Date 06/18/1997
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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