HDL CHOLESTEROL REAGENT

Ldl & Vldl Precipitation, Hdl

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Hdl Cholesterol Reagent.

Pre-market Notification Details

Device IDK911406
510k NumberK911406
Device Name:HDL CHOLESTEROL REAGENT
ClassificationLdl & Vldl Precipitation, Hdl
Applicant GENZYME CORP. ONE KENDALL SQUARE Cambridge,  MA  02139
ContactRussell H Herndon
CorrespondentRussell H Herndon
GENZYME CORP. ONE KENDALL SQUARE Cambridge,  MA  02139
Product CodeLBR  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-03-29
Decision Date1991-05-22

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