GEM Premier 5000 (Measured Parameters:Glucose, Lactate And Total Bilirubin)

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 5000 (measured Parameters:glucose, Lactate And Total Bilirubin).

Pre-market Notification Details

Device IDK160402
510k NumberK160402
Device Name:GEM Premier 5000 (Measured Parameters:Glucose, Lactate And Total Bilirubin)
ClassificationGlucose Oxidase, Glucose
Applicant Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
ContactCarol Murble
CorrespondentCarol Marble
Instrumentation Laboratory Co. 180 Hartwell Road Bedford,  MA  01730
Product CodeCGA  
Subsequent Product CodeKHP
Subsequent Product CodeMQM
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-12
Decision Date2016-12-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08426950807667 K160402 000
08426950807568 K160402 000

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