GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

Test, Cystatin C

GENZYME CORPORATION

The following data is part of a premarket notification filed by Genzyme Corporation with the FDA for Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator.

Pre-market Notification Details

Device IDK080662
510k NumberK080662
Device Name:GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
ClassificationTest, Cystatin C
Applicant GENZYME CORPORATION 31 NEW YORK AVENUE Framingham,  MA  01701 -9322
ContactEric Lawson
CorrespondentEric Lawson
GENZYME CORPORATION 31 NEW YORK AVENUE Framingham,  MA  01701 -9322
Product CodeNDY  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-10
Decision Date2008-05-15
Summary:summary

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