FDA 510(k)

Omics Core

K-Number: K190661 · 2019-11-09

Decision Date2019-11-09

Product CodePZM

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

Omics Core is the device name listed in this FDA 510(k) record. The listed applicant is Nanthealth, Inc.. It received FDA 510(k) clearance on 2019-11-09 under 510(k) 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. The listed applicant is Nanthealth, Inc.. The 510(k) number is K190661.

When did Omics Core receive FDA 510(k) clearance?

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

Who is the listed applicant for Omics Core?

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

What is the FDA product code for Omics Core?

The FDA product code for Omics Core is PZM.

Related Devices (Code: 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.