VITROS Chemistry Products GLU Slides

Glucose Oxidase, Glucose

Ortho Clinical Diagnostics

The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Chemistry Products Glu Slides.

Pre-market Notification Details

Device IDK163433
510k NumberK163433
Device Name:VITROS Chemistry Products GLU Slides
ClassificationGlucose Oxidase, Glucose
Applicant Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester,  NY  14626
ContactDarlene J. Phillips
CorrespondentDarlene J. Phillips
Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester,  NY  14626
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-07
Decision Date2017-09-18
Summary:summary

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