ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE

Glucose Oxidase, Glucose

BAYER HEALTHCARE, DIAGNOSTICS DIVISION

The following data is part of a premarket notification filed by Bayer Healthcare, Diagnostics Division with the FDA for Advia Chemistry Glucose Oxidase Assay And Advia Chemistry Glucose Hexokinase.

Pre-market Notification Details

Device IDK042015
510k NumberK042015
Device Name:ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA CHEMISTRY GLUCOSE HEXOKINASE
ClassificationGlucose Oxidase, Glucose
Applicant BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactAndres Holle
CorrespondentAndres Holle
BAYER HEALTHCARE, DIAGNOSTICS DIVISION 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-07-27
Decision Date2004-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414595634 K042015 000
00630414578941 K042015 000
00630414526720 K042015 000

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