N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET

Ldl & Vldl Precipitation, Hdl

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for N-geneous Ldl Cholesterol Reagent, N-geneous Ldl Cholesterol Calibrator, Genzyme Ldl Cholesterol Control Set.

Pre-market Notification Details

Device IDK971573
510k NumberK971573
Device Name:N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET
ClassificationLdl & Vldl Precipitation, Hdl
Applicant GENZYME CORP. ONE KENDALL SQUARE Cambridge,  MA  02139
ContactNancy E Isaac
CorrespondentNancy E Isaac
GENZYME CORP. ONE KENDALL SQUARE Cambridge,  MA  02139
Product CodeLBR  
Subsequent Product CodeJIS
Subsequent Product CodeJIX
CFR Regulation Number862.1475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-30
Decision Date1997-06-18
Summary:summary

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