GEM PREMIER 3000

Glucose Oxidase, Glucose

INSTRUMENTATION LABORATORY CO.

The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 3000.

Pre-market Notification Details

Device IDK052121
510k NumberK052121
Device Name:GEM PREMIER 3000
ClassificationGlucose Oxidase, Glucose
Applicant INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
ContactCarol Marble
CorrespondentCarol Marble
INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford,  MA  01730
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-05
Decision Date2005-10-21
Summary:summary

NIH GUDID Devices

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