510(k) DEN090004
- Device
- OVA1 TEST
- Applicant
- Vermillion
- 510(k) number
- DEN090004
- Product code
- ONX
- Decision
- Unknown (DENG)
- Decision date
- 2009-09-11
- Date received
- 2009-07-22
- Regulation
- 866.6050
- Classification name
- Ovarian Adnexal Mass Assessment Score Test System
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- GILLIAN CRUTCHER
- Address
- 47350 Fremont Blvd. Fremont CA US 94538 94538
FDA Registration Numbers#
- 1415939
- 3004869564
- 3002809144
- 2521625
- 3005333358
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ONX#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153607 | ROMA Calculation Tool Using Elecsys Assays | Roche Diagnostics | 2016-06-15 |
| K160090 | Lumipulse G ROMA | Fujirebio Diagnostics,Inc. | 2016-05-16 |
| K151502 | ARCHITECT ROMA | Fujirebio Diagnostics,Inc. | 2016-04-28 |
| K150588 | OVA1 Next Generation | Vermillion, Inc. | 2016-03-18 |
| K103358 | ROMA (HE4 EIA + ARCHITECT CA 125 II) | Fujirebio Diagnostics,Inc. | 2011-09-01 |