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510(k) K190661

Device
Omics Core
Applicant
NantHealth, Inc.
510(k) number
K190661
Product code
PZM  
Decision
Substantially Equivalent (SESE)
Decision date
2019-11-09
Date received
2019-03-14
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
Aleece Nolasco
Address
9920 Jefferson Blvd. Culver City CA US 90232 90232

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PZM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260235CellDx-TissueDatar Cancer Genetics Private Limited2026-05-12
K241868xR IVDTempus AI, Inc.2025-09-19
K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc.2025-08-29
K210017ACTOnco, ACTOnco IVDAct Genomics2022-12-23
K202304NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)Nyu Langone Medical Center2021-07-14
K192063PGDx elio tissue completePersonal Genome Diagnostics2020-04-24
DEN170058MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets):a Hybridization-Capture Based Next Generation Sequencing AssayMemorial Sloan-Kettering Cancer Center2017-11-15

Legacy Summary#

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FDA Review#

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