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FDA 510(k)

OVA1 Next Generation

K-Number: K150588 · 2016-03-18

ApplicantVermillion, Inc.
Decision Date2016-03-18
Product CodeONX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OVA1 Next Generation is the device name listed in this FDA 510(k) record. The listed applicant is Vermillion, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K150588. The device is classified under product code ONX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OVA1 Next Generation?

OVA1 Next Generation is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is Vermillion, Inc.. The 510(k) number is K150588.

When did OVA1 Next Generation receive FDA 510(k) clearance?

OVA1 Next Generation received FDA 510(k) clearance on 2016-03-18, under 510(k) number K150588.

Who is the listed applicant for OVA1 Next Generation?

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

What is the FDA product code for OVA1 Next Generation?

The FDA product code for OVA1 Next Generation is ONX.

Related Devices (Code: ONX)

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.

K153607ROMA Calculation Tool Using Elecsys AssaysRoche DiagnosticsK160090Lumipulse G ROMAFujirebio Diagnostics,Inc.K151502ARCHITECT ROMAFujirebio Diagnostics,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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