Documento fuente o registro público
FDA 510(k) K193493 — ADVIA Centaur Total IgE (tIgE)
FDA 510(k) index record K193493. Device: ADVIA Centaur Total IgE (tIgE). Applicant as listed: Siemens Healthcare Diagnostics, Inc.. Decision date: 2020-01-15.
Fuente
"device_name": "ADVIA Centaur Total IgE (tIgE)"
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2026-10-20
2026-10-20
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FDA 510(k) public index record K193493.
Device name: ADVIA Centaur Total IgE (tIgE). Applicant as listed: Siemens Healthcare Diagnostics, Inc..
Decision date: 2020-01-15. Decision wording: Substantially Equivalent.
Product code: DGC. Regulation: 21 CFR 866.5510. 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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