Documento fuente o registro público
FDA 510(k) K203564 — SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay
FDA 510(k) index record K203564. Device: SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay. Applicant as listed: Immunalysis Corporation. Decision date: 2021-12-22.
Fuente
"device_name": "SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-31
professional use
FDA 510(k) public index record K203564.
Device name: SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay. Applicant as listed: Immunalysis Corporation.
Decision date: 2021-12-22. Decision wording: Substantially Equivalent.
Product code: DJG. Regulation: 21 CFR 862.3650. Medical specialty: Clinical Toxicology.
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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