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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 a medical device manufactured by Act Genomics. It received FDA 510(k) clearance on 2022-12-23 under approval 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. It is manufactured by Act Genomics. The 510(k) number is K210017.

When was ACTOnco, ACTOnco IVD approved by the FDA?

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

What company makes ACTOnco, ACTOnco IVD?

ACTOnco, ACTOnco IVD is manufactured by Act Genomics.

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

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

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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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