Documento fuente o registro público
FDA 510(k) K190710 — EliA SymphonyS Immunoassay
FDA 510(k) index record K190710. Device: EliA SymphonyS Immunoassay. Applicant as listed: Phadia AB. Decision date: 2019-11-29.
Fuente
"device_name": "EliA SymphonyS Immunoassay"
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Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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FDA 510(k) public index record K190710.
Device name: EliA SymphonyS Immunoassay. Applicant as listed: Phadia AB.
Decision date: 2019-11-29. Decision wording: Substantially Equivalent.
Product code: LLL. Regulation: 21 CFR 866.5100. 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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