CellDx-Tissue— 510(k) K260235

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.

Clearance details

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