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FDA 510(k)

ACTOnco, ACTOnco IVD

K-Number: K210017 · 2022-12-23

ApplicantAct Genomics
Decision Date2022-12-23
Product CodePZM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

ACTOnco, ACTOnco IVD is the device name listed in this FDA 510(k) record. The listed applicant is Act Genomics. It received FDA 510(k) clearance on 2022-12-23 under 510(k) number K210017. 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 ACTOnco, ACTOnco IVD?

ACTOnco, ACTOnco IVD is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is Act Genomics. The 510(k) number is K210017.

When did ACTOnco, ACTOnco IVD receive FDA 510(k) clearance?

ACTOnco, ACTOnco IVD received FDA 510(k) clearance on 2022-12-23, under 510(k) number K210017.

Who is the listed applicant for ACTOnco, ACTOnco IVD?

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

What is the FDA product code for ACTOnco, ACTOnco IVD?

The FDA product code for ACTOnco, ACTOnco IVD is PZM.

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.K202304NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets)Nyu Langone Medical CenterK192063PGDx elio tissue completePersonal Genome DiagnosticsK190661Omics CoreNanthealth, Inc.

Official Source

View on FDA Database →

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

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