NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS

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 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips.

Pre-market Notification Details

Device IDK112638
510k NumberK112638
Device Name:NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
ClassificationSystem, Test, Blood Glucose, Over The Counter
Applicant NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham,  MA  02454
ContactPaul W Macdonald
CorrespondentPaul W Macdonald
NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham,  MA  02454
Product CodeNBW  
Subsequent Product CodeJJX
Subsequent Product CodeLFR
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-09
Decision Date2012-03-09
Summary:summary

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