FDA 510(k)

CellDx-Tissue

K-Number: K260235 · 2026-05-12

ApplicantDatar Cancer Genetics Private Limited

Decision Date2026-05-12

Product CodePZM

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

CellDx-Tissue is the device name listed in this FDA 510(k) record. The listed applicant is Datar Cancer Genetics Private Limited. It received FDA 510(k) clearance on 2026-05-12 under 510(k) number K260235. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CellDx-Tissue?

CellDx-Tissue is a medical device that received FDA 510(k) clearance on 2026-05-12. The listed applicant is Datar Cancer Genetics Private Limited. The 510(k) number is K260235.

When did CellDx-Tissue receive FDA 510(k) clearance?

CellDx-Tissue received FDA 510(k) clearance on 2026-05-12, under 510(k) number K260235.

Who is the listed applicant for CellDx-Tissue?

The FDA 510(k) record lists Datar Cancer Genetics Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CellDx-Tissue?

The FDA product code for CellDx-Tissue is PZM.

Related Devices (Code: PZM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241868xR IVDTempus AI, Inc.K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc.K210017ACTOnco, ACTOnco IVDAct Genomics K202304NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)Nyu Langone Medical Center K192063PGDx elio tissue completePersonal Genome Diagnostics K190661Omics CoreNanthealth, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.