CellDx-Tissue
K-Number: K260235 · 2026-05-12
Decision Date2026-05-12
Product CodePZM
Advisory CommitteePA
DecisionSubstantially Equivalent
Device Summary
CellDx-Tissue is a medical device manufactured by Datar Cancer Genetics Private Limited. It received FDA 510(k) clearance on 2026-05-12 under approval 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. It is manufactured by Datar Cancer Genetics Private Limited. The 510(k) number is K260235.
When was CellDx-Tissue approved by the FDA?
CellDx-Tissue received FDA 510(k) clearance on 2026-05-12, under approval number K260235.
What company makes CellDx-Tissue?
CellDx-Tissue is manufactured by Datar Cancer Genetics Private Limited.
What is the FDA product code for CellDx-Tissue?
The FDA product code for CellDx-Tissue is PZM.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.