ACCU-CHEK AVIVA PLUS SYSTEM

System, Test, Blood Glucose, Over The Counter

ROCHE DIAGNOSTICS CORPORATION

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

Pre-market Notification Details

Device IDK133862
510k NumberK133862
Device Name:ACCU-CHEK AVIVA PLUS SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis,  IN  46250
ContactKhone Saysana
CorrespondentKhone Saysana
ROCHE DIAGNOSTICS CORPORATION 9115 Hague Road Indianapolis,  IN  46250
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-19
Decision Date2014-04-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00365702725102 K133862 000
10365702724102 K133862 000
00365702723108 K133862 000
00365702702394 K133862 000

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