Source document or public record
FDA 510(k) K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track
FDA 510(k) index record K230937. Device: Alinity i Total ß-hCG Reagent Kit, GLP systems Track. Applicant as listed: Abbott Laboratories. Decision date: 2023-06-05.
Source
"device_name": "Alinity i Total ß-hCG Reagent Kit, GLP systems Track"
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 K230937.
Device name: Alinity i Total ß-hCG Reagent Kit, GLP systems Track. Applicant as listed: Abbott Laboratories.
Decision date: 2023-06-05. Decision wording: Substantially Equivalent.
Product code: DHA. Regulation: 21 CFR 862.1155. 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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