FDA 510(k)

TRUE METRIX GO Self Monitoring Blood Glucose System

K-Number: K143548 · 2016-04-01

Decision Date2016-04-01

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TRUE METRIX GO Self Monitoring Blood Glucose System is a medical device manufactured by Trividia Health, Inc.. It received FDA 510(k) clearance on 2016-04-01 under approval number K143548. 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 TRUE METRIX GO Self Monitoring Blood Glucose System?

TRUE METRIX GO Self Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2016-04-01. It is manufactured by Trividia Health, Inc.. The 510(k) number is K143548.

When was TRUE METRIX GO Self Monitoring Blood Glucose System approved by the FDA?

TRUE METRIX GO Self Monitoring Blood Glucose System received FDA 510(k) clearance on 2016-04-01, under approval number K143548.

What company makes TRUE METRIX GO Self Monitoring Blood Glucose System?

TRUE METRIX GO Self Monitoring Blood Glucose System is manufactured by Trividia Health, Inc..

What is the FDA product code for TRUE METRIX GO Self Monitoring Blood Glucose System?

The FDA product code for TRUE METRIX GO Self Monitoring Blood Glucose System is NBW. This falls under the OB/GYN category.

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Official Source

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