510(k) K260235
- Device
- CellDx-Tissue
- Applicant
- Datar Cancer Genetics Private Limited
- 510(k) number
- K260235
- Product code
- PZM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-12
- Date received
- 2026-01-26
- Regulation
- 866.6080
- Classification name
- Next Generation Sequencing Based Tumor Profiling Test
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Y
Applicant Contact#
- Contact
- Dadasaheb Akolkar
- Address
- F-8, D Rd. Ambad Nasik IN 422010 422010
FDA Registration Numbers#
- 3003335080
- 3043140667
- 3013200421
- 3043050156
- 3011805506
Source Documents#
Other 510(k) Records For Product Code PZM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241868 | xR IVD | Tempus AI, Inc. | 2025-09-19 |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | 2025-08-29 |
| K210017 | ACTOnco, ACTOnco IVD | Act Genomics | 2022-12-23 |
| K202304 | NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) | Nyu Langone Medical Center | 2021-07-14 |
| K192063 | PGDx elio tissue complete | Personal Genome Diagnostics | 2020-04-24 |
| K190661 | Omics Core | Nanthealth, Inc. | 2019-11-09 |
| DEN170058 | MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing Assay | Memorial Sloan-Kettering Cancer Center | 2017-11-15 |