StatStrip Glucose Hospital Meter

Glucose Oxidase, Glucose

NOVA BIOMEDICAL CORPORATION

The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Statstrip Glucose Hospital Meter.

Pre-market Notification Details

Device IDK150281
510k NumberK150281
Device Name:StatStrip Glucose Hospital Meter
ClassificationGlucose Oxidase, Glucose
Applicant NOVA BIOMEDICAL CORPORATION 200 PROSPECT STREET Waltham,  MA  02454 -9141
ContactPaul W. Macdonald
CorrespondentPaul W. Macdonald
NOVA BIOMEDICAL CORPORATION 200 PROSPECT STREET Waltham,  MA  02454 -9141
Product CodeCGA  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-05
Decision Date2015-05-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00385480547901 K150281 000
10385480544228 K150281 000
10385480544198 K150281 000
10385480534397 K150281 000
10385480486306 K150281 000
10385480486290 K150281 000

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