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FDA 510(k)

StatStrip Xpress Glucose Hospital Meter System

K-Number: K161856 · 2016-11-15

ApplicantNova Biomedical Corporation
Decision Date2016-11-15
Product CodePZI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

StatStrip Xpress Glucose Hospital Meter System is a medical device manufactured by Nova Biomedical Corporation. It received FDA 510(k) clearance on 2016-11-15 under approval number K161856. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StatStrip Xpress Glucose Hospital Meter System?

StatStrip Xpress Glucose Hospital Meter System is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Nova Biomedical Corporation. The 510(k) number is K161856.

When was StatStrip Xpress Glucose Hospital Meter System approved by the FDA?

StatStrip Xpress Glucose Hospital Meter System received FDA 510(k) clearance on 2016-11-15, under approval number K161856.

What company makes StatStrip Xpress Glucose Hospital Meter System?

StatStrip Xpress Glucose Hospital Meter System is manufactured by Nova Biomedical Corporation.

What is the FDA product code for StatStrip Xpress Glucose Hospital Meter System?

The FDA product code for StatStrip Xpress Glucose Hospital Meter System is PZI.

Related Clinical Trials

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Other Devices by Nova Biomedical Corporation

K160156StatStrip Xpress Blood Glucose Monitoring System K152986StatStrip Xpress 2 Glucose Hospital Meter System K170464StatStrip Xpress Blood Glucose Monitoring 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: PZI)

K152986StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation K163490StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation K182549StatStrip Xpress 2 Glucose Hospital Meter SystemNova Biomedical Corporation K181043StatStrip Glucose Hospital Meter SystemNova Biomedical Corporation K200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc.

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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