K260235
- 510(k) number
- K260235
- Device name
- CellDx-Tissue
- Applicant
- Datar Cancer Genetics Private Limited IN
- Product code
- PZM — Next Generation Sequencing Based Tumor Profiling Tes
- Decision date
- 2026-05-12
- Date received
- 2026-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Pathology
PDFDownload 510(k) SummaryArchived here · 3.4 MB · U.S. public domain
Also available from FDA: K260235.pdf
Official FDA record: K260235
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.