TRUE METRIX GO Self Monitoring Blood Glucose System

FDA 510(k) K143548 · Trividia Health, Inc.

Substantially Equivalent

510(k) numberK143548

Submission

Device name
TRUE METRIX GO Self Monitoring Blood Glucose System
Applicant
Trividia Health, Inc.
Fort Lauderdale, FL, US
Received
December 15, 2014
Decision date
April 1, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NBW – System, Test, Blood Glucose, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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More from Ascensia Diabetes Care

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Questions and answers

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

TRUE METRIX GO Self Monitoring Blood Glucose System (K143548) received a 510(k) decision of Substantially Equivalent on April 1, 2016, 473 days after the submission was received.

What is the product code of K143548?

The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.