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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 the device name listed in this FDA 510(k) record. The listed applicant is Nova Biomedical Corporation. It received FDA 510(k) clearance on 2016-11-15 under 510(k) 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. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K161856.

When did StatStrip Xpress Glucose Hospital Meter System receive FDA 510(k) clearance?

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

Who is the listed applicant for StatStrip Xpress Glucose Hospital Meter System?

The FDA 510(k) record lists Nova Biomedical Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Nova Biomedical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: PZI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252323cobas pulse blood glucose monitoring systemRoche DiagnosticsK221349XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemTaidoc Technology CorporationK220272cobas pulse blood glucose monitoring systemRoche DiagnosticsK232075StatStrip Glucose Hospital Meter SystemNova Biomedical CorporationK200788Assure Titanium Blood Glucose Monitoring SystemArkray, Inc.K182552StatStrip Xpress Glucose Hospital Meter SystemNova Biomedical Corporation

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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