OVA1 Next Generation— 510(k) K150588

Substantially Equivalent

Vermillion, Inc.

FDA 510(k) clearance K150588 for OVA1 Next Generation, Substantially Equivalent on 2016-03-18. Applicant: Vermillion, Inc..

Clearance details

Applicant: Vermillion, Inc.
Product code: Code ONX
Advisory panel: Obstetrics/Gynecology
Date received: 2015-03-09
Decision date: 2016-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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