Documento fuente o registro público
FDA 510(k) K223503 — Access 25(OH) Vitamin D Total
FDA 510(k) index record K223503. Device: Access 25(OH) Vitamin D Total. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-01-19.
Fuente
"device_name": "Access 25(OH) Vitamin D Total"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-30
professional use
FDA 510(k) public index record K223503.
Device name: Access 25(OH) Vitamin D Total. Applicant as listed: Beckman Coulter, Inc..
Decision date: 2023-01-19. 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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