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FDA 510(k)

Nova StatSensor Creatinine Hospital Meter System

K-Number: K171059 · 2017-05-26

ApplicantNova Biomedical Corporation
Decision Date2017-05-26
Product CodeCGL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Nova StatSensor Creatinine 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 2017-05-26 under 510(k) number K171059. The device is classified under product code CGL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nova StatSensor Creatinine Hospital Meter System?

Nova StatSensor Creatinine Hospital Meter System is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Nova Biomedical Corporation. The 510(k) number is K171059.

When did Nova StatSensor Creatinine Hospital Meter System receive FDA 510(k) clearance?

Nova StatSensor Creatinine Hospital Meter System received FDA 510(k) clearance on 2017-05-26, under 510(k) number K171059.

Who is the listed applicant for Nova StatSensor Creatinine 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 Nova StatSensor Creatinine Hospital Meter System?

The FDA product code for Nova StatSensor Creatinine Hospital Meter System is CGL.

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.

K251281Nova Max Creat eGFR Monitoring SystemK252206Nova Allegro UACR Assay, Nova Allegro AnalyzerK221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerK221813Nova Allegro UACR Assay, Nova Allegro AnalyzerK232075StatStrip Glucose Hospital Meter SystemK221900Stat Profile Prime Plus Analyzer System

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Related Devices (Code: CGL)

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.

K261039i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, 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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