StatStrip Xpress Glucose Hospital Meter System

Prescription Use Blood Glucose Meter For Near-patient Testing

Nova Biomedical Corporation

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

Pre-market Notification Details

Device IDK182552
510k NumberK182552
Device Name:StatStrip Xpress Glucose Hospital Meter System
ClassificationPrescription Use Blood Glucose Meter For Near-patient Testing
Applicant Nova Biomedical Corporation 200 Prospect Street Waltham,  MA  02454
ContactKhushboo Surendran
CorrespondentKhushboo Surendran
Nova Biomedical Corporation 200 Prospect Street Waltham,  MA  02454
Product CodePZI  
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeDual Track
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-17
Decision Date2018-12-13
Summary:summary

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