Documento fuente o registro público
FDA 510(k) K260235 — CellDx-Tissue
FDA 510(k) index record K260235. Device: CellDx-Tissue. Applicant as listed: Datar Cancer Genetics Private Limited. Decision date: 2026-05-12.
Fuente
"device_name": "CellDx-Tissue"
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
2026-10-22
professional use
FDA 510(k) public index record K260235.
Device name: CellDx-Tissue. Applicant as listed: Datar Cancer Genetics Private Limited.
Decision date: 2026-05-12. Decision wording: Substantially Equivalent.
Product code: PZM. Regulation: 21 CFR 866.6080. Medical specialty: Pathology.
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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