510(k) K103358
- Device
- ROMA (HE4 EIA + ARCHITECT CA 125 II)
- Applicant
- FUJIREBIO DIAGNOSTICS, INC.
- 510(k) number
- K103358
- Product code
- ONX
- Decision
- Se - With Limitations (SESU)
- Decision date
- 2011-09-01
- Date received
- 2010-11-16
- Regulation
- 866.6050
- Classification name
- Ovarian Adnexal Mass Assessment Score Test System
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIANA L DICKSON
- Address
- 201 Great Valley Pkwy. Malvern PA US 19355 19355
FDA Registration Numbers#
- 1415939
- 3004869564
- 3002809144
- 2521625
- 3005333358
Source Documents#
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 |
| DEN090004 | OVA1 TEST | Vermillion | 2009-09-11 |
Legacy Summary#
summary
FDA Review#
Decision Summary