TRUE METRIX GO Self Monitoring Blood Glucose System— 510(k) K143548

Substantially Equivalent

Trividia Health, Inc.

FDA 510(k) clearance K143548 for TRUE METRIX GO Self Monitoring Blood Glucose System, Substantially Equivalent on 2016-04-01. Applicant: Trividia Health, Inc..

Clearance details

Applicant: Trividia Health, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2014-12-15
Decision date: 2016-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.