CellDx-Tissue— 510(k) K260235

Name: FDA 510(k) clearance K260235
Creator: U.S. Food and Drug Administration
Published: 2026-05-12

Substantially Equivalent

Datar Cancer Genetics Private Limited

FDA 510(k) clearance K260235 for CellDx-Tissue, Substantially Equivalent on 2026-05-12. Applicant: Datar Cancer Genetics Private Limited. Device class: 2.

Summary

Datar Cancer Genetics' CellDx-Tissue is filed under PZM, next generation sequencing based tumor profiling tests.

Class II, 21 CFR 866.6080. Pathology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Datar filed from Nasik, India. Review took 106 calendar days (January 26 to May 12, 2026). The record flags it as a third-party review.

Clearance details

Applicant: Datar Cancer Genetics Private Limited
Product code: Product code PZM
Device class: Class 2
Regulation: 21 CFR 866.6080
Advisory panel: Pathology
Date received: 2026-01-26
Decision date: 2026-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nasik, IN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.