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510(k) Submission – OVA1 Next Generation (K150588, Vermillion Inc)
510(k) Submission – OVA1 Next Generation (K150588, Vermillion Inc)
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510(K) Number: K150588
Device Name: OVA1 Next Generation
Manufacturer: VERMILLION, INC.
Device Classification Name: Ovarian Adnexal Mass Assessment Score Test System
Regulation Number: 866.6050
Classification Product Code: ONX
Date Received: 03/09/2015
Decision Date: 03/18/2016
Regulation Medical Specialty: Obstetrics/Gynecology
Request Contents: 510(k) Application number K150588, Trade/Device Name: OVA1 Next Generation Submitted by Vermillion Inc Groups 1 to 7, Sections 1 to 20
Device Name: OVA1 Next Generation
Manufacturer: VERMILLION, INC.
Device Classification Name: Ovarian Adnexal Mass Assessment Score Test System
Regulation Number: 866.6050
Classification Product Code: ONX
Date Received: 03/09/2015
Decision Date: 03/18/2016
Regulation Medical Specialty: Obstetrics/Gynecology
Request Contents: 510(k) Application number K150588, Trade/Device Name: OVA1 Next Generation Submitted by Vermillion Inc Groups 1 to 7, Sections 1 to 20
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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