Documento fuente o registro público
FDA 510(k) K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack
FDA 510(k) index record K231517. Device: VITROS Immunodiagnostic Products CEA Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics. Decision date: 2023-08-23.
Fuente
"device_name": "VITROS Immunodiagnostic Products CEA Reagent Pack"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-28
professional use
FDA 510(k) public index record K231517.
Device name: VITROS Immunodiagnostic Products CEA Reagent Pack. Applicant as listed: Ortho Clinical Diagnostics.
Decision date: 2023-08-23. Decision wording: Substantially Equivalent.
Product code: DHX. Regulation: 21 CFR 866.6010. 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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