CellDx-Tissue
FDA 510(k) clearance K260235 · decided 2026-05-12
Clearance details
- K-number
- K260235
- Device name
- CellDx-Tissue
- Applicant
- Datar Cancer Genetics Private Limited
- Decision
- Substantially Equivalent
- Date received
- 2026-01-26
- Decision date
- 2026-05-12
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- PZM
- Device class
- 2
- Regulation number
- 866.6080
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Nasik, IN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.