Source document or public record

FDA 510(k) K262116 — TRUE METRIX Self Monitoring Blood Glucose System

FDA 510(k) index record K262116. Device: TRUE METRIX Self Monitoring Blood Glucose System. Applicant as listed: Trividia Health, Inc.. Decision date: 2026-07-23.

OtherU.S. Food and Drug Administration (FDA)2026-07-23

Source

"device_name": "TRUE METRIX Self Monitoring Blood Glucose System"

This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.

Review and references

Reviewer

Automated FDA record verification

Published

2026-10-20

Updated

2026-10-20

Disclaimer

professional use

FDA 510(k) public index record K262116.

Device name: TRUE METRIX Self Monitoring Blood Glucose System. Applicant as listed: Trividia Health, Inc..

Decision date: 2026-07-23. Decision wording: Substantially Equivalent.

Product code: NBW. Regulation: 21 CFR 862.1345. Medical specialty: Clinical Chemistry.

This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.

Interested in these solutions?

Submit a sourcing request with the assays, volumes, and timeline of your own project.