ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM

System, Test, Blood Glucose, Over The Counter

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Accu-chek Inform Ii Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK121679
510k NumberK121679
Device Name:ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactMike Flis
CorrespondentMike Flis
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeNBW  
Subsequent Product CodeJJX
Subsequent Product CodeLFR
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-07
Decision Date2012-10-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336155332 K121679 000
07613336155318 K121679 000
07613336141953 K121679 000
04015630945757 K121679 000
04015630943319 K121679 000
04015630942473 K121679 000

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