Source document or public record
FDA 510(k) K232587 — MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
FDA 510(k) index record K232587. Device: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer. Applicant as listed: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Decision date: 2024-04-12.
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"device_name": "MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer"
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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2026-10-20
2026-10-20
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FDA 510(k) public index record K232587.
Device name: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer. Applicant as listed: Shenzhen New Industries Biomedical Engineering Co., Ltd..
Decision date: 2024-04-12. Decision wording: Substantially Equivalent.
Product code: MRG. Regulation: 21 CFR 862.1825. 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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