Source document or public record
FDA 510(k) K203771 — Urea Nitrogen2
FDA 510(k) index record K203771. Device: Urea Nitrogen2. Applicant as listed: Abbott Ireland Diagnostics Division. Decision date: 2022-05-31.
Source
"device_name": "Urea Nitrogen2"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
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Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K203771.
Device name: Urea Nitrogen2. Applicant as listed: Abbott Ireland Diagnostics Division.
Decision date: 2022-05-31. Decision wording: Substantially Equivalent.
Product code: CDQ. Regulation: 21 CFR 862.1770. 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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