GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL

Assay, Glycosylated Hemoglobin

GENZYME CORP.

The following data is part of a premarket notification filed by Genzyme Corp. with the FDA for Glypro Reagent, Glypro Calibrator, Glypro Low Control, Glypro High Control.

Pre-market Notification Details

Device IDK983726
510k NumberK983726
Device Name:GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
ClassificationAssay, Glycosylated Hemoglobin
Applicant GENZYME CORP. 500 KENDALL STREET Cambridge,  MA  02142 -1562
ContactBarbara Pizza
CorrespondentBarbara Pizza
GENZYME CORP. 500 KENDALL STREET Cambridge,  MA  02142 -1562
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-22
Decision Date1998-11-25
Summary:summary

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