Source document or public record
FDA 510(k) K191562 — Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
FDA 510(k) index record K191562. Device: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor. Applicant as listed: HORIBA ABX SAS. Decision date: 2020-03-06.
Source
"device_name": "Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor"
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 K191562.
Device name: Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor. Applicant as listed: HORIBA ABX SAS.
Decision date: 2020-03-06. Decision wording: Substantially Equivalent.
Product code: DBF. Regulation: 21 CFR 866.5340. Medical specialty: Immunology.
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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