Documento fuente o registro público
FDA 510(k) K223038 — Access Cortisol
FDA 510(k) index record K223038. Device: Access Cortisol. Applicant as listed: Beckman Coulter, Inc.. Decision date: 2023-02-08.
Fuente
"device_name": "Access Cortisol"
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Automated FDA record verification
2026-10-20
2026-10-29
professional use
FDA 510(k) public index record K223038.
Device name: Access Cortisol. Applicant as listed: Beckman Coulter, Inc..
Decision date: 2023-02-08. Decision wording: Substantially Equivalent.
Product code: CGR. Regulation: 21 CFR 862.1205. 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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