ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR

Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Ultra N-geneous Hdl Cholesterol Reagent 1/reagent2; Ultra N-geneous Hdl Cholestreol Calibrator.

Pre-market Notification Details

Device IDK021316
510k NumberK021316
Device Name:ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
ClassificationLdl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Applicant GENZYME CORP. ONE KENDALL SQUARE Cambridge,  MA  02139
ContactBarabra Pizza
CorrespondentBarabra Pizza
GENZYME CORP. ONE KENDALL SQUARE Cambridge,  MA  02139
Product CodeLBS  
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-25
Decision Date2002-07-25
Summary:summary

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