OVA1 TEST— 510(k) DEN090004

Unknown

Vermillion

FDA 510(k) clearance DEN090004 for OVA1 TEST, Unknown on 2009-09-11. Applicant: Vermillion. Device class: 2.

Clearance details

Applicant: Vermillion
Product code: Code ONX
Device class: Class 2
Regulation: 21 CFR 866.6050
Advisory panel: Obstetrics/Gynecology
Date received: 2009-07-22
Decision date: 2009-09-11
Decision: Unknown
Clearance type: Post-NSE
Location: Fremont, CA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.