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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 a medical device manufactured by Vermillion, Inc.. It received FDA 510(k) clearance on 2016-03-18 under approval 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. It is manufactured by Vermillion, Inc.. The 510(k) number is K150588.

When was OVA1 Next Generation approved by the FDA?

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

What company makes OVA1 Next Generation?

OVA1 Next Generation is manufactured by Vermillion, Inc..

What is the FDA product code for OVA1 Next Generation?

The FDA product code for OVA1 Next Generation is ONX.

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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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