K-number	K080662
Device name	GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR
Applicant	Genzyme Corporation
Product code	NDY
Device class	Class II
Decision date	May 15, 2008
Decision	Substantially Equivalent
Regulation	862.1225

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View the full FDA submission: accessdata.fda.gov

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GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR

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