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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Low Density, Lipoprotein
510(k) Number K924674
Device Name DIRECT LDL CHOLES IMMUNOSEPARATION REAGENT
Applicant
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Applicant Contact ALODIA M RUIZ
Correspondent
Genzyme Corp.
One Kendall Sq.
Cambridge,  MA  02139
Correspondent Contact ALODIA M RUIZ
Regulation Number862.1475
Classification Product Code
MRR  
Date Received09/16/1992
Decision Date 01/06/1993
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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