StatStrip Xpress Blood Glucose Monitoring System

System, Test, Blood Glucose, Over The Counter

Nova Biomedical Corporation

The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Statstrip Xpress Blood Glucose Monitoring System.

Pre-market Notification Details

Device IDK170464
510k NumberK170464
Device Name:StatStrip Xpress Blood Glucose Monitoring System
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant Nova Biomedical Corporation 200 Prospect Street Waltham,  MA  02454
ContactEliza Wang
CorrespondentEliza Wang
Nova Biomedical Corporation 200 Prospect Street Waltham,  MA  02454
Product CodeNBW  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-15
Decision Date2017-11-07
Summary:summary

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