ACCU-CHEK AVIVA EXPERT SYSTEM

Glucose Dehydrogenase, Glucose

ROCHE DIAGNOSTICS CORPORATION

The following data is part of a premarket notification filed by Roche Diagnostics Corporation with the FDA for Accu-chek Aviva Expert System.

Pre-market Notification Details

Device IDK142089
510k NumberK142089
Device Name:ACCU-CHEK AVIVA EXPERT SYSTEM
ClassificationGlucose Dehydrogenase, Glucose
Applicant ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis,  IN  46250
ContactGreg Mondics
CorrespondentNathan A. Carrington
ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis,  IN  46250
Product CodeLFR  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-01
Decision Date2014-12-17
Summary:summary

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