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FDA 510(k)

StatStrip Xpress Blood Glucose Monitoring System

K-Number: K170464 · 2017-11-07

ApplicantNova Biomedical Corporation
Decision Date2017-11-07
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

StatStrip Xpress Blood Glucose Monitoring System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2017-11-07 under approval number K170464. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StatStrip Xpress Blood Glucose Monitoring System?

StatStrip Xpress Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2017-11-07. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K170464.

When was StatStrip Xpress Blood Glucose Monitoring System approved by the FDA?

StatStrip Xpress Blood Glucose Monitoring System received FDA 510(k) clearance on 2017-11-07, under approval number K170464.

What company makes StatStrip Xpress Blood Glucose Monitoring System?

StatStrip Xpress Blood Glucose Monitoring System is manufactured by Nova Biomedical Corporation.

What is the FDA product code for StatStrip Xpress Blood Glucose Monitoring System?

The FDA product code for StatStrip Xpress Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

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Related PubMed Literature

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Other Devices by Nova Biomedical Corporation

K161856StatStrip Xpress Glucose Hospital Meter System K160156StatStrip Xpress Blood Glucose Monitoring System K152986StatStrip Xpress 2 Glucose Hospital Meter System K171059Nova StatSensor Creatinine Hospital Meter System K160990Nova Max Uric Acid Monitoring System K163490StatStrip Xpress 2 Glucose Hospital Meter System

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Related Devices (Code: NBW)

K161299BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring SystemApex BioTechnology Corp. K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. K161834One Drop Blood Glucose Monitoring SystemAgamatrix, Inc. K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring SystemsTaidoc Technology Corporation K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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