FDA 510(k)

CellDx-Tissue

Número K: K260235 · 2026-05-12

RequerenteDatar Cancer Genetics Private Limited

Data da decisão2026-05-12

Código do produtoPZM

Comité consultivoPA

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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