Documento fuente o registro público
FDA 510(k) K232898 — Quantisal Oral Fluid Collection Device
FDA 510(k) index record K232898. Device: Quantisal Oral Fluid Collection Device. Applicant as listed: Immunalysis Corporation. Decision date: 2023-11-21.
Fuente
"device_name": "Quantisal Oral Fluid Collection Device"
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
2026-10-28
professional use
FDA 510(k) public index record K232898.
Device name: Quantisal Oral Fluid Collection Device. Applicant as listed: Immunalysis Corporation.
Decision date: 2023-11-21. Decision wording: Substantially Equivalent.
Product code: PJD. Regulation: 21 CFR 862.1675. Medical specialty: Clinical Chemistry.
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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