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510(k) K192063

Device
PGDx Elio Tissue Complete
Applicant
Personal Genome Diagnostics
510(k) number
K192063
Product code
PZM  
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-24
Date received
2019-08-01
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
Jennifer Dickey
Address
2809 Boston St. Suite 503 Baltimore MD US 21224 21224

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
K190661Omics CoreNanthealth, Inc.2019-11-09
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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