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FDA 510(k)

PGDx elio tissue complete

K-Number: K192063 · 2020-04-24

ApplicantPersonal Genome Diagnostics
Decision Date2020-04-24
Product CodePZM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PGDx elio tissue complete is the device name listed in this FDA 510(k) record. The listed applicant is Personal Genome Diagnostics. It received FDA 510(k) clearance on 2020-04-24 under 510(k) number K192063. The device is classified under product code PZM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PGDx elio tissue complete?

PGDx elio tissue complete is a medical device that received FDA 510(k) clearance on 2020-04-24. The listed applicant is Personal Genome Diagnostics. The 510(k) number is K192063.

When did PGDx elio tissue complete receive FDA 510(k) clearance?

PGDx elio tissue complete received FDA 510(k) clearance on 2020-04-24, under 510(k) number K192063.

Who is the listed applicant for PGDx elio tissue complete?

The FDA 510(k) record lists Personal Genome Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PGDx elio tissue complete?

The FDA product code for PGDx elio tissue complete is PZM.

Other records listing Personal Genome Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P250036Next generation sequencing oncology panel, somatic or germline variant detection system

Related Devices (Code: PZM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260235CellDx-TissueDatar Cancer Genetics Private LimitedK241868xR IVDTempus AI, Inc.K250003GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005)Geneseeq Technology, Inc.K210017ACTOnco, ACTOnco IVDAct GenomicsK202304NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)Nyu Langone Medical CenterK190661Omics CoreNanthealth, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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