510(k) K210017
- Device
- ACTOnco, ACTOnco IVD
- Applicant
- Act Genomics
- 510(k) number
- K210017
- Product code
- PZM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-23
- Date received
- 2021-01-04
- 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
- No
Applicant Contact#
- Contact
- Pei-Fang Chung
- Address
- 3f, No 345, Xinhu 2nd Rd.., Neihu District Taipei TW 11494 11494
FDA Registration Numbers#
- 3043140667
- 3013200421
- 3003335080
- 3043050156
- 3011805506
Source Documents#
Other 510(k) Records For Product Code PZM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260235 | CellDx-Tissue | Datar Cancer Genetics Private Limited | 2026-05-12 |
| K241868 | xR IVD | Tempus AI, Inc. | 2025-09-19 |
| K250003 | GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) | Geneseeq Technology, Inc. | 2025-08-29 |
| 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 |