Documento fuente o registro público
FDA 510(k) K233605 — ADVIA Centaur EBV-EBNA IgG
FDA 510(k) index record K233605. Device: ADVIA Centaur EBV-EBNA IgG. Applicant as listed: Biokit, S.A.. Decision date: 2024-08-07.
Fuente
"device_name": "ADVIA Centaur EBV-EBNA IgG"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K233605.
Device name: ADVIA Centaur EBV-EBNA IgG. Applicant as listed: Biokit, S.A..
Decision date: 2024-08-07. Decision wording: Substantially Equivalent.
Product code: LLM. Regulation: 21 CFR 866.3235. Medical specialty: Microbiology.
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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