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FDA 510(k)

Omics Core

K-Number: K190661 · 2019-11-09

ApplicantNanthealth, Inc.
Decision Date2019-11-09
Product CodePZM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

Omics Core is a medical device manufactured by Nanthealth, Inc.. It received FDA 510(k) clearance on 2019-11-09 under approval number K190661. 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 Omics Core?

Omics Core is a medical device that received FDA 510(k) clearance on 2019-11-09. It is manufactured by Nanthealth, Inc.. The 510(k) number is K190661.

When was Omics Core approved by the FDA?

Omics Core received FDA 510(k) clearance on 2019-11-09, under approval number K190661.

What company makes Omics Core?

Omics Core is manufactured by Nanthealth, Inc..

What is the FDA product code for Omics Core?

The FDA product code for Omics Core is PZM.

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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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