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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Next Generation Sequencing Based Tumor Profiling Test
510(k) Number K260235
Device Name CellDx-Tissue
Applicant
Datar Cancer Genetics Private Limited
F-8, D Rd.
Ambad
Nasik,  IN 422010
Applicant Contact Dadasaheb Akolkar
Correspondent
Global Quality and Regulatory Services
10 Scenic Way
Monroe,  NJ  08831
Correspondent Contact Abdel B Halim
Regulation Number866.6080
Classification Product Code
PZM  
Date Received01/26/2026
Decision Date 05/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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