Source document or public record
FDA 510(k) K201037 — FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
FDA 510(k) index record K201037. Device: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System. Applicant as listed: Taidoc Technology Corporation. Decision date: 2022-06-16.
Source
"device_name": "FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring 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
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K201037.
Device name: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System. Applicant as listed: Taidoc Technology Corporation.
Decision date: 2022-06-16. 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.