Source document or public record
FDA 510(k) K233655 — Lingo Glucose System
FDA 510(k) index record K233655. Device: Lingo Glucose System. Applicant as listed: Abbott. Decision date: 2024-05-29.
Source
"device_name": "Lingo 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
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K233655.
Device name: Lingo Glucose System. Applicant as listed: Abbott.
Decision date: 2024-05-29. Decision wording: Substantially Equivalent.
Product code: SAF. Regulation: 21 CFR 862.1355. 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.
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